Identity
- Trade Name
- RPS II - Air 10 DC Cable EUDAMEDRPSII FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- RPSII-V2 Air10 PSU Adaptor,RPSII- Stellar DC Cable,RPSII- Stellar 0.5m DC Cable,RPSII- Air10 DC Cable EUDAMEDRPSII - AIR 10 DC CABLE FDA UDI
- Model / Reference
- 37343 EUDAMEDFDA UDI
- Description
- RPSII - AIR 10 DC CABLE FDA UDI
Identifiers
- Catalog Number
- 37343 FDA UDI
- Primary DI / UDI-DI
- 00619498373437 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC2086J 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RPS II - Air 10 DC Cable 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 | 619498EC2086J | 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 614d5cef-0549-4e88-80ba-0b8e27f26445 61 fields · synced Jul 26, 2026
- FDA UDI a64ef57a-7f09-422e-bfbe-20e0daead68d 36 fields · synced May 29, 2026