Aintree C-CAE-19.0-56-AIC-01

GUDID 00827002576261

Aintree Intubation Catheter with Rapi-Fit Adapter

COOK INCORPORATED

Endotracheal tube guide, single-use

• Primary Device ID: 00827002576261
• NIH Device Record Key: 8e89f398-e653-4978-8696-de8fbcdb3dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aintree
• Version Model Number: G57626
• Catalog Number: C-CAE-19.0-56-AIC-01
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002576261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162729

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-06
• Device Publish Date: 2020-03-27

On-Brand Devices [Aintree]

• 00827002576261: Aintree Intubation Catheter with Rapi-Fit Adapter
• 00827002107892: Aintree Intubation Catheter