COOK Medical Sphere™ Inflation Device CID-60-15

GUDID 10827002349039

Inflation Device: 60mL, 15atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 10827002349039
• NIH Device Record Key: 1db71063-138e-4b8e-9a99-3565c033095c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOK Medical Sphere™ Inflation Device
• Version Model Number: QL® 6015
• Catalog Number: CID-60-15
• Company DUNS: 047571476
• Company Name: ATRION MEDICAL PRODUCTS, INC.
• 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: false
• 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(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002349032 [Primary]
GS1	10827002349039 [Package]; Contains: 00827002349032; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• KOE: Dilator, Urethral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-21

On-Brand Devices [COOK Medical Sphere™ Inflation Device]

• 10827002496740: Inflation Device: 40mL, 15atm
• 10827002462837: Inflation Device: 25mL, 15atm
• 10827002349039: Inflation Device: 60mL, 15atm
• 10827002310275: Inflation Device: 20mL, 30atm
• 10827002255712: Inflation Device: 20mL, 30atm