Identity
- Trade Name
- Koala Reusable Cable EUDAMEDKoala® Cables FDA UDI
- Generic Name
- Intrapartum pressure monitoring catheter FDA UDI
- Device Name
- Koala Reusable Cable (Phillips) EUDAMEDCables to IUP catheters: HP8040A 5mV/1350 FDA UDI
- Model / Reference
- IPC-5012 EUDAMEDFDA UDI
- Description
- Cables to IUP catheters: HP8040A 5mV/1350 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247005100RM EUDAMED
- 510(k) Number
- K974389 FDA UDI
- FDA Product Code
- HFN FDA UDI
- EMDN Code
- V9011 MULTIFUNCTIONAL TRANSDUCERS EUDAMED
- GMDN Term
- Intrapartum pressure monitoring catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2700 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Koala Reusable Cable by Clinical Innovations, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0814247005100RM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED 84a18993-4a2f-4ec3-b68c-1654ab4855af 61 fields · synced Jun 17, 2026
- FDA UDI d0dda55e-283c-4af9-9983-8fa1575e19b2 34 fields · synced May 30, 2026