Identity
- Trade Name
- CMI FDA UDI
- Generic Name
- Foetal vacuum extraction system, manual, single-use FDA UDI
- Device Name
- ELBOW PUMP ADAPTER FDA UDI
- Model / Reference
- Adapters FDA UDI
- Description
- ELBOW PUMP ADAPTER FDA UDI
Identifiers
- Catalog Number
- SF-ELBO FDA UDI
- Primary DI / UDI-DI
- H671SFELBO1 FDA UDI
- FDA Product Code
- HDB FDA UDI
- GMDN Term
- Foetal vacuum extraction system, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4340 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foetal vacuum extraction system, manual, single-use
Cmi by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal vacuum extraction system, manual, single-use.
- CMI — Utah Medical Products, Inc. · Class II
- CMI — Utah Medical Products, Inc. · Class II
- CMI — Utah Medical Products, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 8ace4a98-624e-492d-98e6-f683f3d54cd3 35 fields · synced Jun 9, 2026