Identity
- Trade Name
- CBL SpO2 Extension Cable, 2m EUDAMEDNA FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- SPO2 Adapters and Cables EUDAMED
- Model / Reference
- 989803105681 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 989803105681 FDA UDI
- Primary DI / UDI-DI
- 00884838011922 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM562T9 EUDAMED
- 510(k) Number
- K001725 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - 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
- 870.2700 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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
CBL SpO2 Extension Cable, 2m by Philips Medizin Systeme Böblingen GmbH — 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 | 0884838BM562T9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED ad9fda79-377e-4ef7-84d9-0d0a451628cd 61 fields · synced Jul 21, 2026
- FDA UDI 9f8e6df4-b8f1-4ac3-a57d-de850f091273 35 fields · synced May 30, 2026