Identity
- Trade Name
- BiPAP A40 Ventilator, INTL EUDAMEDBiPAP A40 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- BiPAP A40 EUDAMEDBiPAP A40, International FDA UDI
- Model / Reference
- 1111169 EUDAMED00 FDA UDI
- Description
- BiPAP A40, International FDA UDI
Identifiers
- Catalog Number
- 1111169 FDA UDI
- Primary DI / UDI-DI
- 00606959067677 EUDAMED00606959039476 FDA UDI
- Basic UDI-DI
- B-00606959067677 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPAP A40 Ventilator, INTL by Respironics, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959067677 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 91c61a0e-2699-4ebe-ad40-5e7509fce6b1 61 fields · synced Jun 17, 2026
- FDA UDI cdf918ee-ce63-4d02-8f5f-cc0931ead9b8 37 fields · synced May 30, 2026