Identity
- Trade Name
- OBIX FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN FDA UDI
- Model / Reference
- OBIX IM2 FDA UDI
- Description
- OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN FDA UDI
Identifiers
- Catalog Number
- OBIX IM2 FDA UDI
- Primary DI / UDI-DI
- 05051968041234 FDA UDI
- 510(k) Number
- K200975 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal/maternal prenatal monitor
Obix by Huntleigh Healthcare , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200975 also covers:
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
- OBIX — Huntleigh Healthcare , Ltd.
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
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA UDI af4149a6-54ad-4f11-9525-3ca634124a9c 37 fields · synced Jun 6, 2026