FDA.reportPublic FDA data

Cook

Primary DI
00827002142251
Brand
Cook
Company
COOK INCORPORATED
Model
G14225
Catalog number
050030
Device description
Drainage Bag Connector
Published
2020-10-02
Public version status
New
Distribution status
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
EYKCONNECTOR, URETERAL CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYKConnector, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002142251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002142251008270021422518270021422510827002142251

GMDN Terms#

Term, Definition table
TermDefinition
Urethral/suprapubic catheter valve-connectorA small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage). As the bladder is intended to store urine between drainage it may be intended to help maintain bladder tone/capacity. It is typically a small plastic two-way connector with an integrated faucet (stopcock). 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
Premarket exempt
true
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
05906168942235Sealing Connector Y pieceWISMED PL SP Z O OEYK2025-03-17
05906168942242Sealing Connector I Piece WISMED PL SP Z O OEYK2025-03-17
05906168942259Sealing Connector T pieceWISMED PL SP Z O OEYK2025-03-17
08714729298151NABOSTON SCIENTIFIC CORPORATIONEYK2024-10-09
00724995211530UroSealUS EndoscopyEYK2022-11-28
10724995211537UroSealUS EndoscopyEYK2022-11-28
00827002145290CookCOOK INCORPORATEDEYK2020-10-02
00827002162198CookCOOK INCORPORATEDEYK2020-10-02
00827002171077CookCOOK INCORPORATEDEYK2020-10-02
00850005780168GU TekV L V ASSOCIATES (INC)EYK2020-07-15
08714729010944NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010951NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729012832NABOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010975ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010982ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729010999ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24
08714729011002ConnectorBOSTON SCIENTIFIC CORPORATIONEYK2016-09-24