Manufacturer's Devices - Smiths Medical ASD Inc

Address:




6000 Nathan Ln N



Minneapolis

MN 55442

United States


Authorised Representative/ UK Responsible Person
Name: Smiths Medical International Limited
Address:

1500 Eureka Park Lower Pemberton Kennington



Ashford

Kent TN25 4BF

England United Kingdom




Code/Term Type
Configurable electronic form web-based application softwareConfigurable electronic form web-based application softwareClass I
Bedside infusion pump single-channelBedside infusion pump single-channelClass I
Circulating-air whole-body heating system control unitCirculating-air whole-body heating system control unitClass I
Personal device holder reusablePersonal device holder reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Manual chest percussorManual chest percussorClass I
Personal device holder single-usePersonal device holder single-useClass I
Portable/mobile rechargeable battery packPortable/mobile rechargeable battery packClass I
Subcutaneous infusion/injection port needleSubcutaneous infusion/injection port needleClass IIa
Rebreathing oxygen face maskRebreathing oxygen face maskClass IIa
Breathing circuit condensate trap single-useBreathing circuit condensate trap single-useClass IIa
Nasal oxygen cannula basicNasal oxygen cannula basicClass IIa
Tracheostomy mask oxygenTracheostomy mask oxygenClass IIa
Non-rebreathing oxygen face maskNon-rebreathing oxygen face maskClass IIa
Oxygen administration tubingOxygen administration tubingClass IIa
Oxygen administration face tentOxygen administration face tentClass IIa
Patient monitoring system module interfacingPatient monitoring system module interfacingClass I
Infant limb immobilizer reusableInfant limb immobilizer reusableClass I
Intravenous pressure infusor manual reusableIntravenous pressure infusor manual reusableClass I
Needle guardNeedle guardClass I
Intravenous line recessed-needle connectorIntravenous line recessed-needle connectorClass I
Incentive spirometerIncentive spirometerClass I
Medical tubing clip/clamp temporary non-calibrated reusableMedical tubing clip/clamp temporary non-calibrated reusableClass I
Medical networking interface unitMedical networking interface unitClass I
Blood pressure transducer holderBlood pressure transducer holderClass I
Electrode/transducer strap reusableElectrode/transducer strap reusableClass I
Endotracheal tube introducer reusableEndotracheal tube introducer reusableClass I
Arm procedure positioner reusableArm procedure positioner reusableClass I
Medical device service rail clampMedical device service rail clampClass I
Endotracheal tube guide reusableEndotracheal tube guide reusableClass I
Blood pressure cuff inflator manualBlood pressure cuff inflator manualClass I
Respiratory connector disconnection wedgeRespiratory connector disconnection wedgeClass I
Tracheostomy tube decannulation capTracheostomy tube decannulation capClass I
Circulating-air whole-body heating/cooling system pad single-useCirculating-air whole-body heating/cooling system pad single-useClass I
Infusion pump remote controlInfusion pump remote controlClass I
Airway device cleaning utensil noninvasive single-useAirway device cleaning utensil noninvasive single-useClass I
Tracheostomy tube neck holder single-useTracheostomy tube neck holder single-useClass I
Spinal needle single-useSpinal needle single-use Conformity Assessment Certificate ExpiredClass I
Epidural/intrathecal anaesthesia set non-medicatedEpidural/intrathecal anaesthesia set non-medicated Conformity Assessment Certificate ExpiredClass I
Mediastinal drainage catheter non-antimicrobialMediastinal drainage catheter non-antimicrobial Conformity Assessment Certificate ExpiredClass III
Endotracheal tube holderEndotracheal tube holderClass III
Nasopharyngeal airway single-useNasopharyngeal airway single-useClass III
Artificial airway stylet single-useArtificial airway stylet single-useClass I
Endotracheal tube introducer single-useEndotracheal tube introducer single-useClass I
Endotracheal tube guide single-useEndotracheal tube guide single-useClass I
Laryngeal mask airway single-useLaryngeal mask airway single-useClass I
Positive pressure airway secretion-clearing devicePositive pressure airway secretion-clearing deviceClass I
Blood gas syringe IVD sodium heparinBlood gas syringe IVD sodium heparinClass IIa
Blood gas syringe IVD lithium heparinBlood gas syringe IVD lithium heparinClass IIa
CPAP/BPAP oral maskCPAP/BPAP oral mask Conformity Assessment Certificate ExpiredIVD General
Gas-sampling/monitoring respiratory tubing single-useGas-sampling/monitoring respiratory tubing single-use Conformity Assessment Certificate ExpiredIVD General
Metered-delivery hypodermic syringe/needleMetered-delivery hypodermic syringe/needle Conformity Assessment Certificate ExpiredClass IIa
Neutral-pressure intravenous line needleless valve-connectorNeutral-pressure intravenous line needleless valve-connector Conformity Assessment Certificate ExpiredClass IIa
Breathing circuit catheter mount single-useBreathing circuit catheter mount single-use Conformity Assessment Certificate ExpiredClass IIa
Medication transfer setMedication transfer set Conformity Assessment Certificate ExpiredClass IIa
Surgical capillary wound drain non-luminalSurgical capillary wound drain non-luminal Conformity Assessment Certificate ExpiredClass IIa
Insulin syringe/needle basicInsulin syringe/needle basic Conformity Assessment Certificate ExpiredClass IIa
Ink printerInk printer Conformity Assessment Certificate ExpiredClass IIa
Medicine chamber spacer reusableMedicine chamber spacer reusable Conformity Assessment Certificate ExpiredClass IIa
Suction system filter microbialSuction system filter microbial Conformity Assessment Certificate ExpiredClass IIa
Ventilator breathing circuit single-useVentilator breathing circuit single-use Conformity Assessment Certificate ExpiredClass IIa
Anaesthesia breathing circuit single-useAnaesthesia breathing circuit single-use Conformity Assessment Certificate ExpiredClass IIa
Pleural catheterPleural catheter Conformity Assessment Certificate ExpiredClass IIa
Electrical mains power cableElectrical mains power cable Conformity Assessment Certificate ExpiredClass IIa
Cricothyrotomy kit single-useCricothyrotomy kit single-use Conformity Assessment Certificate ExpiredClass IIa
CPAP/BPAP face mask reusableCPAP/BPAP face mask reusable Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube reinforced non-customized single-useTracheostomy tube reinforced non-customized single-use Conformity Assessment Certificate ExpiredClass IIa
Reinforced endotracheal tube reusableElectrical-only medical device connection cable reusable Conformity Assessment Certificate ExpiredClass IIa
Heat/moisture exchanger/microbial medical gas filterReinforced endotracheal tube reusable Conformity Assessment Certificate ExpiredClass IIa
Subcutaneous tunneller single-useHeat/moisture exchanger/microbial medical gas filter Conformity Assessment Certificate ExpiredClass IIa
Subcutaneous tunneller reusableSubcutaneous tunneller single-use Conformity Assessment Certificate ExpiredClass IIa
Airway pressure monitor non-poweredSubcutaneous tunneller reusable Conformity Assessment Certificate ExpiredClass IIa
Reinforced endotracheal tube single-useAirway pressure monitor non-powered Conformity Assessment Certificate ExpiredClass IIa
Peripheral anaesthesia catheter set non-medicatedReinforced endotracheal tube single-use Conformity Assessment Certificate ExpiredClass IIa
Anaesthesia face mask single-usePeripheral anaesthesia catheter set non-medicated Conformity Assessment Certificate ExpiredClass IIa
Basic endotracheal tube reusableAnaesthesia face mask single-use Conformity Assessment Certificate ExpiredClass IIa
NRFit/epidural catheter linear connectorBasic endotracheal tube reusable Conformity Assessment Certificate ExpiredClass IIa
Pulmonary resuscitator manual single-useNRFit/epidural catheter linear connector Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube speech valvePortable/mobile rechargeable battery pack Conformity Assessment Certificate ExpiredClass IIa
Catheter injection portPulmonary resuscitator manual single-use Conformity Assessment Certificate ExpiredClass IIa
Suction/irrigation tubing single-useTracheostomy tube speech valve Conformity Assessment Certificate ExpiredClass IIa
ERCP catheter non-balloon non-electrical single-useCatheter injection port Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube cannula single-useSuction/irrigation tubing single-use Conformity Assessment Certificate ExpiredClass IIa
Closed-wound drain non-bioabsorbableERCP catheter non-balloon non-electrical single-use Conformity Assessment Certificate ExpiredClass IIa
Airway suction catheterTracheostomy tube cannula single-use Conformity Assessment Certificate ExpiredClass IIa
Convection blood/fluid warmer high-flowClosed-wound drain non-bioabsorbable Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube non-reinforced non-customized single-useAirway suction catheter Conformity Assessment Certificate ExpiredClass IIa
Basic endotracheal tube single-useConvection blood/fluid warmer high-flow Conformity Assessment Certificate ExpiredClass IIa
Oxygen administration kit sterileTracheostomy tube non-reinforced non-customized single-use Conformity Assessment Certificate ExpiredClass IIa
Pulse oximeterBedside infusion pump single-channel Conformity Assessment Certificate ExpiredClass IIb
In-line arterial blood sampling setBasic endotracheal tube single-use Conformity Assessment Certificate ExpiredClass IIb
Noninvasive device battery chargerOxygen administration kit sterile Conformity Assessment Certificate ExpiredClass IIb
Vascular port administration setPulse oximeter Conformity Assessment Certificate ExpiredClass IIa
Heat/moisture exchanger single-useIn-line arterial blood sampling set Conformity Assessment Certificate ExpiredClass IIa
Invasive blood pressure monitoring tubing setNoninvasive device battery charger Conformity Assessment Certificate ExpiredClass IIa
Surgical patient preparation kitVascular port administration set Conformity Assessment Certificate ExpiredClass IIa
Aerosol face mask rebreathing single-useHeat/moisture exchanger single-use Conformity Assessment Certificate ExpiredClass IIa
Breathing circuit bag single-useInvasive blood pressure monitoring tubing set Conformity Assessment Certificate ExpiredClass IIa
In-line backflow valve single-useSurgical patient preparation kit Conformity Assessment Certificate ExpiredClass IIa
Tracheobronchial suction/insufflation catheter single-lumenAerosol face mask rebreathing single-use Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration pump reusableBreathing circuit bag single-use Conformity Assessment Certificate ExpiredClass IIa
Aerosol delivery tubingIn-line backflow valve single-use Conformity Assessment Certificate ExpiredClass IIa
Tracheobronchial suction/insufflation catheter dual-lumenTracheobronchial suction/insufflation catheter single-lumen Conformity Assessment Certificate ExpiredClass IIa
Endobronchial tubeSurgical irrigation/aspiration pump reusable Conformity Assessment Certificate ExpiredClass IIa
Anaesthesia conduction filterAerosol delivery tubing Conformity Assessment Certificate ExpiredClass IIa
Infusion pump cassetteTracheobronchial suction/insufflation catheter dual-lumen Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy kit single-useEndobronchial tube Conformity Assessment Certificate ExpiredClass IIa
Incision/drainage kitIncentive spirometer Conformity Assessment Certificate ExpiredClass IIa
Syringe tip capAnaesthesia conduction filter Conformity Assessment Certificate ExpiredClass IIa
Intrathecal anaesthesia set non-medicatedInfusion pump cassette Conformity Assessment Certificate ExpiredClass IIa
Vascular port/catheterTracheostomy kit single-use Conformity Assessment Certificate ExpiredClass IIa
Spinal port/catheterIncision/drainage kit Conformity Assessment Certificate ExpiredClass IIb
Epidural anaesthesia set non-medicatedSyringe tip cap Conformity Assessment Certificate ExpiredClass IIa
Peripheral intravenous cannulaIntrathecal anaesthesia set non-medicated Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube reinforced non-customized reusableVascular port/catheter Conformity Assessment Certificate ExpiredClass IIa
Low-resistance epidural syringeSpinal port/catheter Conformity Assessment Certificate ExpiredClass I
Electrical mains power extension cableSubcutaneous infusion/injection port needle Conformity Assessment Certificate ExpiredClass III
Basic power supply reusableEpidural anaesthesia set non-medicated Conformity Assessment Certificate ExpiredClass III
Infusion pump medication-dosage application softwarePeripheral intravenous cannula Conformity Assessment Certificate ExpiredClass III
Electric infusion pump administration set single-useTracheostomy tube reinforced non-customized reusable Conformity Assessment Certificate ExpiredClass IIa
Heat-exchanging intravenous administration setIntravenous line recessed-needle connector Conformity Assessment Certificate ExpiredClass IIa
Intravenous line filterLow-resistance epidural syringe Conformity Assessment Certificate ExpiredClass IIb
Intravenous administration tubing extension setElectrical mains power extension cable Conformity Assessment Certificate ExpiredClass IIb
Cuff-suction endotracheal tubeBasic power supply reusable Conformity Assessment Certificate ExpiredClass IIb
Tracheostomy tube cannula reusableInfusion pump medication-dosage application software Conformity Assessment Certificate ExpiredClass IIb
Convection blood/fluid warmerInfusion pump remote control Conformity Assessment Certificate ExpiredClass IIa
Temperature-monitoring indwelling urethral drainage catheterCirculating-air whole-body heating system control unit Conformity Assessment Certificate ExpiredClass IIa
Peripheral nerve-block sharp needleElectric infusion pump administration set single-use Conformity Assessment Certificate ExpiredClass IIb
Tube/mask breathing circuit connector single-use sterileHeat-exchanging intravenous administration set Conformity Assessment Certificate ExpiredClass IIb
Straight/elbow breathing circuit connector single-useIntravenous line filter Conformity Assessment Certificate ExpiredClass IIb
Pulmonary function testing filter/mouthpieceIntravenous administration tubing extension set Conformity Assessment Certificate ExpiredClass IIb
Luer/Luer linear connector single-useCuff-suction endotracheal tube Conformity Assessment Certificate ExpiredClass IIb
Bedside physiologic monitoring softwareTracheostomy tube cannula reusable Conformity Assessment Certificate ExpiredClass IIa
Hypodermic needle single-useConvection blood/fluid warmer Conformity Assessment Certificate ExpiredClass IIa
Basic intravenous administration set noninvasiveTemperature-monitoring indwelling urethral drainage catheter Conformity Assessment Certificate ExpiredClass IIa
Vascular catheter introduction set nonimplantablePeripheral nerve-block sharp needle Conformity Assessment Certificate ExpiredClass IIa
Blood collection set invasiveTube/mask breathing circuit connector single-use sterile Conformity Assessment Certificate ExpiredClass IIa
Epidural needle non-threadedStraight/elbow breathing circuit connector single-use Conformity Assessment Certificate ExpiredClass IIa
Blood gas syringe/needle sodium heparinPulmonary function testing filter/mouthpiece Conformity Assessment Certificate ExpiredClass IIb
Blood gas syringe/needle lithium heparinLuer/Luer linear connector single-use Conformity Assessment Certificate ExpiredClass IIb
Medical printer paperBedside physiologic monitoring software Conformity Assessment Certificate ExpiredClass IIb
Ambulatory insulin infusion administration setHypodermic needle single-use Conformity Assessment Certificate ExpiredClass IIb
Electronic oesophageal stethoscope single-useBasic intravenous administration set noninvasive Conformity Assessment Certificate ExpiredClass IIb
Portable pneumatic ventilatorVascular catheter introduction set nonimplantable Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube non-reinforced non-customized reusableBlood collection set invasive Conformity Assessment Certificate ExpiredClass IIa
General-purpose patient temperature probe single-useEpidural needle non-threaded Conformity Assessment Certificate ExpiredClass IIa
Invasive-pressure external transducer reusableBlood gas syringe/needle sodium heparin Conformity Assessment Certificate ExpiredClass IIa
Tracheostoma buttonBlood gas syringe/needle lithium heparin Conformity Assessment Certificate ExpiredClass IIa
Pulmonary resuscitator pneumatic reusableMedical printer paper Conformity Assessment Certificate ExpiredClass IIa
Bedside syringe pumpAmbulatory insulin infusion administration set Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration cannula non-illuminating single-useElectronic oesophageal stethoscope single-use Conformity Assessment Certificate ExpiredClass IIa
Tracheostomy tube guidewirePortable pneumatic ventilator Conformity Assessment Certificate ExpiredClass IIa
Luer/epidural catheter linear connectorTracheostomy tube non-reinforced non-customized reusable Conformity Assessment Certificate ExpiredClass IIa
Oropharyngeal airway single-useGeneral-purpose patient temperature probe single-use Conformity Assessment Certificate ExpiredClass IIa
Frame/rail/pole device holderInvasive-pressure external transducer reusable Conformity Assessment Certificate ExpiredClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileTracheostoma button Conformity Assessment Certificate ExpiredClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterilePulmonary resuscitator pneumatic reusable Conformity Assessment Certificate ExpiredClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileBedside syringe pump Conformity Assessment Certificate ExpiredClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileSurgical irrigation/aspiration cannula non-illuminating single-use Conformity Assessment Certificate ExpiredClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileTracheostomy tube guidewire Conformity Assessment Certificate ExpiredClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileLuer/epidural catheter linear connector Conformity Assessment Certificate ExpiredClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileOropharyngeal airway single-use Conformity Assessment Certificate ExpiredClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileOropharyngeal airway single-useClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileFrame/rail/pole device holderClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileInfusion pump medication-dosage application softwareClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileBasic power supply reusableClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIb
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass IIa
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I
Circulating-air whole-body heating/cooling system pad single-use sterileCirculating-air whole-body heating/cooling system pad single-use sterileClass I