Bakri J-SOS-100500

GUDID 10827002306735

Bakri Postpartum Balloon 100% Silicone Contains No Latex

COOK INCORPORATED

Intrauterine haemostatic balloon catheter

• Primary Device ID: 10827002306735
• NIH Device Record Key: 6dcffab5-8bbc-4e21-b27a-37ac8c051002
• Commercial Distribution Discontinuation: 2025-12-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bakri
• Version Model Number: G30673
• Catalog Number: J-SOS-100500
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002306735 [Primary]

FDA Product Code

• OQY: Intrauterine tamponade balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-12-04
• Device Publish Date: 2016-09-24

On-Brand Devices [Bakri]

• 10827002590943: Bakri Essential Postpartum Balloon
• 10827002306735: Bakri Postpartum Balloon 100% Silicone Contains No Latex
• 10827002242378: Bakri Postpartum Balloon With Rapid Instillation Components