Identity
- Trade Name
- NOVII INTERFACE CABLE - GE UA EUDAMEDNOVII INTERFACE CABLE FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- NOVII INTERFACE CABLE EUDAMEDNOVII INTERFACE CABLE - GE UA FDA UDI
- Model / Reference
- 105-PT-106 EUDAMEDGE UA FDA UDI
- Description
- NOVII INTERFACE CABLE - GE UA FDA UDI
Identifiers
- Catalog Number
- 105-PT-106 FDA UDI
- Primary DI / UDI-DI
- 05060433670138 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00136H6 EUDAMED
- Direct Marketing DI
- 05060433670138 EUDAMED
- 510(k) Number
- K140862 FDA UDI
- FDA Product Code
- OSP FDA UDI
- EMDN Code
- Z1208010480 CARDIOTOCOGRAPHIC TELEMETRY 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
- 884.2720 FDA UDI
- Market of Registration
- France 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
Yes
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
Yes
Category: Electrical-only medical device connection cable, reusable
Novii Interface Cable by Datex-Ohmeda Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reusable.
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Cleared under the same submission
K140862 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
Sources (2)
- FDA UDI 47cfd82a-1251-4d52-b5e3-95462d4acf3f 36 fields · synced Jul 30, 2026
- EUDAMED 2c3edc60-18ac-4b79-9647-baf10ef646d9 61 fields · synced Jul 30, 2026