FDA.reportPublic FDA data

Cook

Primary DI
00827002273016
Brand
Cook
Company
COOK INCORPORATED
Model
G27301
Catalog number
CTU14.0-38-ST
Device description
Vinyl Connecting Tube
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCDCONNECTOR, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002273016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002273016008270022730168270022730160827002273016

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, single-use, sterileA sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50749756399147DeRoyalDEROYAL INDUSTRIES, INC.GCD2025-06-19
24026704911855PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
50192253042908ArgyleCardinal Health 200, LLCGCD2025-03-07
50192253042830ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042854ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042861ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042878ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042885ArgyleCardinal Health 200, LLCGCD2025-02-27
24026704933123PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933130PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933147PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933154PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
07540198003016FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
07540198003115FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
04710961934967Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934974Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934981Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934998Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935001Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935018Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935025Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935032Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935049Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935056Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935063Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935070Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935087Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935094Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935100Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935117Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31