Bakri®

GUDID 00888937027846

Bakri® Postpartum Balloon with Rapid Instillation Components

Coopersurgical, Inc.

Intrauterine haemostatic balloon catheter

• Primary Device ID: 00888937027846
• NIH Device Record Key: a3f18e97-ac19-4ee4-a726-dae5488ae979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bakri®
• Version Model Number: J-SOSR-100500
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937027846 [Primary]

FDA Product Code

• OQY: Intrauterine Tamponade Balloon

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: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [Bakri®]

• 00888937027853: Bakri® Postpartum Balloon
• 00888937027846: Bakri® Postpartum Balloon with Rapid Instillation Components