FDA.reportPublic FDA data

Bakri

Primary DI
10827002306735
Brand
Bakri
Company
COOK INCORPORATED
Model
G30673
Catalog number
J-SOS-100500
Device description
Bakri Postpartum Balloon 100% Silicone Contains No Latex
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQYIntrauterine tamponade balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQYIntrauterine Tamponade BalloonObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002306735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700230673510827002306735

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine haemostatic balloon catheterA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937027846Bakri®Coopersurgical, Inc.OQY2025-12-10
00888937027853Bakri®Coopersurgical, Inc.OQY2025-12-10
00827002590946BakriCOOK INCORPORATEDOQY2023-02-28
10827002590943BakriCOOK INCORPORATEDOQY2023-02-28
00840164521139JADA SystemOrganon LLCOQY2023-02-15
60840164521131JADA SystemOrganon LLCOQY2023-02-15
00850017882003Jada™ SystemAlydia Health, Inc.OQY2020-10-15
10827002242378BakriCOOK INCORPORATEDOQY2016-09-24
H671BTC1000BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTCESY0BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTC1001BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTCESY1BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
00814247020765Ebb® Complete Tamponade SystemCLINICAL INNOVATIONS, LLCOQY2016-09-01