Identity
- Trade Name
- Aintree FDA UDI
- Generic Name
- Endotracheal tube guide, single-use FDA UDI
- Device Name
- Aintree Intubation Catheter with Rapi-Fit Adapter FDA UDI
- Model / Reference
- G57626 FDA UDI
- Description
- Aintree Intubation Catheter with Rapi-Fit Adapter FDA UDI
Identifiers
- Catalog Number
- C-CAE-19.0-56-AIC-01 FDA UDI
- Primary DI / UDI-DI
- 00827002576261 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
Aintree 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.
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- 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 |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 8e89f398-e653-4978-8696-de8fbcdb3dac 37 fields · synced Jun 8, 2026