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Roll Stand, Transcutaneous CO2 Connection Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1146885
Identity
- Trade Name
- Roll Stand, Transcutaneous CO2 Connection Cable EUDAMEDBiPAP FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- CPAP and BiPAP EUDAMEDTranscutaneous CO2 Connection Cable FDA UDI
- Model / Reference
- 1146885 EUDAMEDFDA UDI
- Description
- Transcutaneous CO2 Connection Cable FDA UDI
Identifiers
- Catalog Number
- 1146885 FDA UDI
- Primary DI / UDI-DI
- 00606959061231 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM136LW EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Roll Stand, Transcutaneous CO2 Connection Cable 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 | 0606959BM136LW | 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 (3)
- EUDAMED aab27d32-24df-48c2-9d0b-7c79b0068bb1 61 fields · synced Jul 12, 2026
- FDA UDI b28a4b3e-9114-4be7-bed2-f46c6ab43ad2 35 fields · synced May 30, 2026
- EUDAMED 92b8913b-9e73-403e-a129-db3d4f90c1d6 61 fields · synced Jul 12, 2026