Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Endotracheal tube guide, single-use FDA UDI
- Device Name
- Cook Airway Exchange Catheter with Rapi-Fit Adapters FDA UDI
- Model / Reference
- G57622 FDA UDI
- Description
- Cook Airway Exchange Catheter with Rapi-Fit Adapters FDA UDI
Identifiers
- Catalog Number
- C-CAE-14.0-83-01 FDA UDI
- Primary DI / UDI-DI
- 00827002576223 FDA UDI
- 510(k) Number
- K162729 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Endotracheal tube guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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: Endotracheal tube guide, single-use
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube guide, single-use.
- JEM 350 Endotracheal Tube Changer — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- VYGON — Vygon Corp. · Class I
- JEM 400 Endotracheal Tube Changer — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- JEM 340 Endotracheal Tube Changer — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- JEM 355 Endotracheal Tube Changer — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Cleared under the same submission
K162729 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 365ee11b-ecd1-4155-b168-f491f2beddbb 37 fields · synced Jun 8, 2026