Identity
- Trade Name
- RPSII - Battery Coupler Kit EUDAMEDRPSII FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- RPSII Battery Coupler Kit, ResMed Power Station II-V2 EUDAMEDRPS II- BATTERY COUPLER KIT FDA UDI
- Model / Reference
- 24964 EUDAMEDFDA UDI
- Description
- RPS II- BATTERY COUPLER KIT FDA UDI
Identifiers
- Catalog Number
- 24964 FDA UDI
- Primary DI / UDI-DI
- 00619498249640 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC11468 EUDAMED
- FDA Product Code
- BZD 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 UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RPSII - Battery Coupler Kit by Resmed Pty Ltd — 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 | 619498EC11468 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED 44533f81-f404-48f6-bc93-9ab0e7ec9d0d 61 fields · synced Jun 19, 2026
- FDA UDI 3a915206-abf4-4cf4-8488-c5b8123f8a64 35 fields · synced May 30, 2026