Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Retrograde endotracheal intubation kit FDA UDI
- Device Name
- Cook Retrograde Intubation Set FDA UDI
- Model / Reference
- G57614 FDA UDI
- Description
- Cook Retrograde Intubation Set FDA UDI
Identifiers
- Catalog Number
- C-RETRO-14.0-70-38J-110-CAE-01 FDA UDI
- Primary DI / UDI-DI
- 00827002576148 FDA UDI
- FDA Product Code
- QCX FDA UDI
- GMDN Term
- Retrograde endotracheal intubation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5095 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: Retrograde endotracheal intubation kit
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Retrograde endotracheal intubation kit.
- MedSource Intubation Kit — MEDSOURCE INTERNATIONAL LLC
- MedSource Intubation Kit — MEDSOURCE INTERNATIONAL LLC
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Cook — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI f1c40201-0a19-4200-aa45-558a402b2f11 36 fields · synced Jun 8, 2026