FDA.reportPublic FDA data

Cook

Primary DI
00827002170278
Brand
Cook
Company
COOK INCORPORATED
Model
G17027
Catalog number
050046-S3
Device description
Connecting Tube
Published
2017-08-22
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
FCNUrinary drainage collection kit, for indwelling catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002170278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002170278008270021702788270021702780827002170278

GMDN Terms#

Term, Definition table
TermDefinition
Urethral/ureteral catheter connector, sterileA small, sterile, connecting device intended to create a mechanical union between the proximal end of urethral and/or ureteral catheter and an external device (e.g., irrigation/vacuum unit, syringe, urine drainage bag) to enable infusion, drainage, or other procedures to be performed through the lumen of the catheter; it has no additional functions (e.g., not a two-way valve). It may also be intended to connect a urinary condom catheter (a penis sheath-type catheter) to a urine drainage bag. 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
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
10192253051629DoverCardinal Health 200, LLCFCN2025-11-07
00661392002388LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
00661392025646LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
10840330701751ProCureTwin Med, LLCFCN2025-05-31
10840330701768ProCureTwin Med, LLCFCN2025-05-31
10840330701775ProCureTwin Med, LLCFCN2025-05-31
10840330701782ProCureTwin Med, LLCFCN2025-05-31
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
00850058254791TruCathHR PHARMACEUTICALS INC.FCN2025-01-16
10192253027686DoverCardinal Health 200, LLCFCN2024-10-14
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14
10192253065480DoverCardinal Health 200, LLCFCN2024-09-03
10192253065497DoverCardinal Health 200, LLCFCN2024-09-03
10192253065619DoverCardinal Health 200, LLCFCN2024-09-03
10192253065626DoverCardinal Health 200, LLCFCN2024-09-03
50192253065488DoverCardinal Health 200, LLCFCN2024-09-03
50192253065495DoverCardinal Health 200, LLCFCN2024-09-03
50192253065617DoverCardinal Health 200, LLCFCN2024-09-03
50192253065624DoverCardinal Health 200, LLCFCN2024-09-03
10192253051612DoverCardinal Health 200, LLCFCN2024-08-08
50192253051610DoverCardinal Health 200, LLCFCN2024-08-08
10850053289085SURGYCOSurgyco LLCFCN2023-12-15
10850053289092SURGYCOSurgyco LLCFCN2023-12-15
10850053289108SURGYCOSurgyco LLCFCN2023-12-15