Identity
- Trade Name
- PAP Li Ion Battery Kit, Sleep, NA EUDAMEDBattery FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- PAP/Respiratory Lithium Ion EUDAMEDLI ION Battery Kit, Sleep, North America FDA UDI
- Model / Reference
- 1124009 EUDAMEDPAP Li Ion Battery Kit, Sleep, NA FDA UDI
- Description
- LI ION Battery Kit, Sleep, North America FDA UDI
Identifiers
- Catalog Number
- 1124009 FDA UDI
- Primary DI / UDI-DI
- 00606959033276 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM141LP EUDAMED
- Direct Marketing DI
- 00606959033276 EUDAMED
- FDA Product Code
- BZD FDA UDICBK FDA UDIMNS FDA UDIMNT FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI868.5895 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PAP Li Ion Battery Kit, Sleep, NA 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 | 0606959BM141LP | 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 238e8f33-f797-4383-968a-4fae429449c1 61 fields · synced Jun 18, 2026
- FDA UDI f9db0025-1bf0-4a78-a193-374f004f31ea 36 fields · synced May 30, 2026