Identity
- Trade Name
- Novii+ Pod EUDAMEDNOVII FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- Novii+ Wireless Patch System EUDAMEDNOVII+ POD FDA UDI
- Model / Reference
- 5514130 EUDAMEDNOVII+ POD FDA UDI
- Description
- NOVII+ POD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278115171 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00458HX EUDAMED
- Direct Marketing DI
- 00195278115171 EUDAMED
- 510(k) Number
- K231964 FDA UDI
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z1208010403 TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY EUDAMED
- GMDN Term
- Foetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Market of Registration
- France 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Foetal/maternal prenatal monitor
Novii by Datex-Ohmeda Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (2)
- FDA UDI 9a2ce7db-91d9-438f-92fa-f4a1e51469b9 35 fields · synced Jun 18, 2026
- EUDAMED ea6b7053-406c-4d41-909d-9ed201145cc8 61 fields · synced Jun 18, 2026