Identity
- Trade Name
- Kaye FDA UDI
- Generic Name
- Intrauterine haemostatic balloon catheter FDA UDI
- Device Name
- Kaye Nephrostomy Tamponade Balloon Catheter Set FDA UDI
- Model / Reference
- G14343 FDA UDI
- Description
- Kaye Nephrostomy Tamponade Balloon Catheter Set FDA UDI
Identifiers
- Catalog Number
- 086014 FDA UDI
- Primary DI / UDI-DI
- 00827002143432 FDA UDI
- FDA Product Code
- LJE FDA UDI
- GMDN Term
- Intrauterine haemostatic balloon catheter FDA UDI
Classification
- Device Class
- U 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: Intrauterine haemostatic balloon catheter
Kaye by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intrauterine haemostatic balloon catheter.
- Ebb® Complete Tamponade System — Clinical Innovations, LLC · Class II
- BT-CATH — Utah Medical Products, Inc. · Class II
- Cook — COOK INCORPORATED · Class II
- Bakri — COOK INCORPORATED · Class II
- Kaye — COOK INCORPORATED · U
- Bakri — COOK INCORPORATED · Class II
- Bakri — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · 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 U | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI be8bde9a-0336-4672-93bd-b085bfc73a94 36 fields · synced Jun 8, 2026