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Nellcor Compatible SpO2 Interconnect Cables
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2021406-001
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Nellcor Compatible SpO2 Interconnect Cables EUDAMEDOXIMAX, 3M ,2021406-001 FDA UDI
- Model / Reference
- 2021406-001 EUDAMEDOXIMAX, 3M ,2021406-001 FDA UDI
- Description
- OXIMAX, 3M ,2021406-001 FDA UDI
Identifiers
- Catalog Number
- 2021406-001 FDA UDI
- Primary DI / UDI-DI
- 00840682103060 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00050GT EUDAMED
- Direct Marketing DI
- 00840682103060 EUDAMED
- 510(k) Number
- K051367 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - 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
- 870.1025 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
MR Unsafe FDA UDI
Nellcor Compatible SpO2 Interconnect Cables by GE Healthcare Finland Oy — 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 | 8406821BUG00050GT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 235eb5b2-5884-4198-9b9f-e144c96591d1 61 fields · synced Oct 6, 2026
- FDA UDI f5079678-5aa6-4da6-9c88-a6b06d5dead7 37 fields · synced May 29, 2026