Bakri

Basic Information

• Brand Name: Bakri
• Primary DI: 00827002590946
• Version / Model: G59094
• Catalog Number: J-SOS-100500-V
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-28
• Public Version: 1
• Public Version Date: 2023-03-08
• Public Version Status: New
• Public Device Record Key: ad1e513d-3c7c-4cca-99ab-d064491debc0

Device Description

Bakri Essential Postpartum Balloon

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OQY	Intrauterine tamponade balloon	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12155	Intrauterine haemostatic balloon catheter	A sterile, flexible tube with an inflatable balloon at its distal end intended to be inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. It may have an additional balloon inflated in the upper vagina to seal the uterine cavity. Devices associated with balloon inflation may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10827002590943	GS1	EA	5	In Commercial Distribution
Primary	00827002590946	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K223098	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.