Identity
- Trade Name
- INTRAN FDA UDI
- Generic Name
- Intrapartum pressure monitoring catheter FDA UDI
- Device Name
- Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Reusable Cable, Regular Size Tip FDA UDI
- Model / Reference
- Plus FDA UDI
- Description
- Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Reusable Cable, Regular Size Tip FDA UDI
Identifiers
- Catalog Number
- IUP-600 FDA UDI
- Primary DI / UDI-DI
- H671IUP6000 FDA UDI
- FDA Product Code
- HFN FDA UDIKXO FDA UDI
- GMDN Term
- Intrapartum pressure monitoring catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intrapartum pressure monitoring catheter
Intran by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intrapartum pressure monitoring catheter.
- Koala® — Clinical Innovations, LLC · Class II
- Koala® Cables — Clinical Innovations, LLC · Class II
- Koala® Cables — Clinical Innovations, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- Kendall — Cardinalhealth · Class II
- Koala® Cables — Clinical Innovations, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- Koala® Cables — Clinical Innovations, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 98f83c44-a3d7-4aad-b4af-7e7c3c42ea8e 36 fields · synced Jun 9, 2026