Identity
- Trade Name
- Reusable Sp02 Adaptor Cable EUDAMEDUnimed FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Reusable SpO2 Adaptor/Extension Cable EUDAMEDSpO2 interface cable/Marquette-Oximax/2.2M/064+170/Nellcor FDA UDI
- Model / Reference
- U708-21P EUDAMEDFDA UDI
- Description
- SpO2 interface cable/Marquette-Oximax/2.2M/064+170/Nellcor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945664804172 EUDAMEDFDA UDI
- Basic UDI-DI
- 69456648RSC12Q EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
Reusable Sp02 Adaptor Cable by Unimed Medical Supplies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69456648RSC12Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Unimed Medical Supplies, Inc
- EUDAMED SRN
- CN-MF-000001480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 80093a89-e6e5-48a5-91a7-172ae7f4f407 61 fields · synced Jul 18, 2026
- FDA UDI 812f5805-c66b-4b1a-9bf1-5280881b9b6e 33 fields · synced May 30, 2026