Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- Cook CVC Single Lumen Central Venous Catheter Set FDA UDI
- Model / Reference
- G58986 FDA UDI
- Description
- Cook CVC Single Lumen Central Venous Catheter Set FDA UDI
Identifiers
- Catalog Number
- ESLMY-5.0-32J-1-15 FDA UDI
- Primary DI / UDI-DI
- 00827002589865 FDA UDI
- 510(k) Number
- K182252 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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: Central venous catheterization kit, short-term
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182252 also covers:
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
- Cook Incorporated
Sources (1)
- FDA UDI 0f87bc57-36a6-41bc-b8f8-fd5dde02e5e8 37 fields · synced Jun 8, 2026