Identity
- Trade Name
- Venni / Biolight FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- Venni / Biolight Fetal Monitor FDA UDI
- Model / Reference
- F90 FDA UDI
- Description
- Venni / Biolight Fetal Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852503007211 FDA UDI
- 510(k) Number
- K131941 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Foetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal/maternal prenatal monitor
Venni / Biolight by Venni Instruments Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal/maternal prenatal monitor.
- Cetro America Ultrasound Transducer 1.150MHz, for Sonomed with blue lemo conne — Cetro America · Class II
- Cetro America Ultrasound Transducer for HP8040, Waterproof — Cetro America · Class II
- Ameritus Transducer — KENTEC MEDICAL, INC. · Class II
- OBIX — Huntleigh Healthcare , Ltd. · Class II
- OBIX — Huntleigh Healthcare , Ltd. · Class II
- Novii — Datex-Ohmeda Inc. · Class II
- SONICAID — Huntleigh Healthcare , Ltd. · Class II
- COROMETRICS 170 SERIES — Wipro GE Healthcare Private Ltd · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Venni Instruments Inc.
Sources (1)
- FDA UDI 7ed71129-d3b3-49a9-a8d3-22c8b2d66ed6 34 fields · synced May 30, 2026