Identity
- Trade Name
- Koala® FDA UDI
- Generic Name
- Intrapartum pressure monitoring catheter FDA UDI
- Device Name
- Koala® Intrauterine Pressure Catheter with internal balloon FDA UDI
- Model / Reference
- IPC-5000C FDA UDI
- Description
- Koala® Intrauterine Pressure Catheter with internal balloon FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020154 FDA UDI
- 510(k) Number
- K974389 FDA UDI
- FDA Product Code
- HFN 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
Yes
FDA UDI
Category: Intrapartum pressure monitoring catheter
Koala® by Clinical Innovations, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
Sources (1)
- FDA UDI d89b02ce-47bf-49c5-a8d5-7533e3e25fd0 34 fields · synced Jun 9, 2026