Identity
- Trade Name
- BiPAP A40 In-Use Case EUDAMEDBiPAP A40 FDA UDI
- Generic Name
- Ventilator stand FDA UDI
- Device Name
- BiPAP A40 In Use Case EUDAMEDA40 In-Use Case FDA UDI
- Model / Reference
- 1098513 EUDAMEDA40 In-Use Case FDA UDI
- Description
- A40 In-Use Case FDA UDI
Identifiers
- Catalog Number
- 1098513 FDA UDI
- Primary DI / UDI-DI
- 00606959043121 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM104LH EUDAMED
- Direct Marketing DI
- 00606959043121 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z1203019099 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT – OTHER EUDAMED
- GMDN Term
- Ventilator stand FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPAP A40 In-Use Case by Respironics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM104LH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED c83c9cc1-6175-49c2-bce3-94f17a9f3f85 61 fields · synced Jun 18, 2026
- FDA UDI 323ce622-efe3-43e7-9ace-12ac96d758d8 35 fields · synced May 30, 2026