FDA.reportPublic FDA data

Cook

Primary DI
00827002179394
Brand
Cook
Company
COOK INCORPORATED
Model
G17939
Catalog number
UDPS-200
Device description
Pediatric Urinary Drain Bag Set With Velcro Strap and Foley Adapter
Published
2017-08-09
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
FFHCOLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFHCollector, Urine, Pediatric, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002179394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002179394008270021793948270021793940827002179394

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). 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
00840118613675ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-10
00840118613682ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-10
00840118611596ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-01
00840118613668ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-01
00801741045820Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045837Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045844Davol® Infant Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045851Davol® Pediatric Cath KitC. R. Bard, Inc.FFH2016-09-06
20801741045824Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045834Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045841Davol® Infant Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045858Davol® Pediatric Cath KitC. R. Bard, Inc.FFH2016-09-06