Arndt C-CAE-14.0-70-LMA-01

GUDID 00827002576254

Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters

COOK INCORPORATED

Endotracheal tube guide, single-use

• Primary Device ID: 00827002576254
• NIH Device Record Key: d0b4aeb8-3fd4-41c4-9289-5c55ede0a754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arndt
• Version Model Number: G57625
• Catalog Number: C-CAE-14.0-70-LMA-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	00827002576254 [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

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• 00827002082519: Arndt Emergency Cricothyrotomy Catheter Set
• 00827002576254: Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters
• 00827002441200: Arndt Endobronchial Blocker Set With Spherical Balloon
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• 00827002441149: Arndt Endobronchial Blocker Set With Spherical Balloon
• 00827002441118: Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon
• 00827002441095: Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon
• 00827002269071: Arndt Endobronchial Blocker Set With Spherical Balloon
• 00827002119208: Arndt Airway Exchange Catheter