Manufacturer's Devices - Pulmodyne Inc
Address:
2055 Executive Drive
Indianapolis
Indiana 46241
United States
Authorised Representative/ UK Responsible Person
Name: Intersurgical Ltd
Address:
Crane House Molly Millars Lane
Wokingham
Berkshire RG41 2RZ
England United Kingdom
| Code/Term |
|
Type |
| Exhaled-gas oesophageal intubation detector adult | Exhaled-gas oesophageal intubation detector adult | Class I
|
| Atomizer non-ventilatory | Atomizer non-ventilatory | Class I
|
| Airway pressure monitor non-powered | Airway pressure monitor non-powered | Class I
|
| In-line CPAP set non-nebulizing | In-line CPAP set non-nebulizing | Class IIa
|
| Cricothyrotomy kit single-use | Cricothyrotomy kit single-use | Class IIa
|
| Ventilator breathing circuit single-use | Ventilator breathing circuit single-use | Class IIa
|
| CPAP/BPAP nasal mask single-use | CPAP/BPAP nasal mask single-use | Class IIa
|
| CPAP/BPAP face mask single-use | CPAP/BPAP face mask single-use | Class IIa
|
| Pulmonary resuscitator manual single-use | Pulmonary resuscitator manual single-use | Class IIa
|
| Heat/moisture exchanger/microbial medical gas filter | Heat/moisture exchanger/microbial medical gas filter | Class IIa
|
| Heat/moisture exchanger single-use | Heat/moisture exchanger single-use | Class IIa
|
| Microbial medical gas filter single-use | Microbial medical gas filter single-use | Class IIa
|
| In-line CPAP gas flow management unit adjustable | In-line CPAP gas flow management unit adjustable | Class IIa
|
| In-line CPAP gas flow management unit non-adjustable | In-line CPAP gas flow management unit non-adjustable | Class IIa
|