Identity
- Trade Name
- Detachable Battery Module EUDAMEDBiPAP A40 FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- Detachable Battery Module EUDAMEDA40 ProEFL, Detachable Battery Module FDA UDI
- Model / Reference
- 3000DBM EUDAMEDFDA UDI
- Description
- A40 ProEFL, Detachable Battery Module FDA UDI
Identifiers
- Catalog Number
- 3000DBM FDA UDI
- Primary DI / UDI-DI
- 00606959056817 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM103LF EUDAMED
- Direct Marketing DI
- 00606959056817 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Noninvasive device battery charger 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Detachable Battery Module 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 | 0606959BM103LF | 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
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 63b87835-e84b-4dfb-8d47-542df8fa8019 61 fields · synced Jun 17, 2026
- FDA UDI f52debc4-881d-4497-992e-4b7d7bf3aec0 35 fields · synced May 30, 2026