FDA.reportPublic FDA data

Cook

Primary DI
00827002145290
Brand
Cook
Company
COOK INCORPORATED
Model
G14529
Catalog number
053003
Device description
Female Foley Adapter
Published
2020-10-02
Public version status
Update
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
00827002145290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002145290008270021452908270021452900827002145290

GMDN Terms#

Term, Definition table
TermDefinition
Luer/non-ISO80369-standardized linear connector, single-useA small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. 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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

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
00827002142251CookCOOK 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