Novii Interface Cable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NOVII INTERFACE CABLE - GE MECG EUDAMEDNovii+ Interface EUDAMEDNOVII INTERFACE CABLE FDA UDINOVII FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDIFoetal/maternal prenatal monitor FDA UDI
- Device Name
- NOVII INTERFACE CABLE EUDAMEDNovii+ Wireless Patch System EUDAMEDMonica Interface CTG Cable - GE Corometrics MECG round green connector FDA UDINOVII+ INTERFACE FDA UDI
- Model / Reference
- 105-PT-104 EUDAMED5514131 EUDAMEDGE MECG FDA UDINOVII+ INTERFACE FDA UDI
- Description
- Monica Interface CTG Cable - GE Corometrics MECG round green connector FDA UDINOVII+ INTERFACE FDA UDI
Identifiers
- Catalog Number
- 105-PT-104 FDA UDI
- Primary DI / UDI-DI
- 05060433670114 EUDAMEDFDA UDI00195278212313 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00136H6 EUDAMED8406821BUG00458HX EUDAMED
- Direct Marketing DI
- 05060433670114 EUDAMED00195278212313 EUDAMED
- FDA Product Code
- OSP FDA UDIHGM FDA UDI
- EMDN Code
- Z1208010480 CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ1208010402 RECEIVING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDIFoetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2720 FDA UDI884.2740 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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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 |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
Sources (4)
- FDA UDI bbc7e5d6-2571-48e7-bdfe-363cde4dd83a 36 fields · synced Jun 20, 2026
- FDA UDI b77def75-b61c-4901-a7b8-c481fc81106d 35 fields · synced May 30, 2026
- EUDAMED ded56ab6-57f1-4bb5-b8f4-e5237cf51fc9 61 fields · synced Jun 18, 2026
- EUDAMED 032a264c-0945-44a4-b2f5-1cb3d8469960 61 fields · synced Jun 20, 2026