FDA.reportPublic FDA data

Cook

Primary DI
00827002015524
Brand
Cook
Company
COOK INCORPORATED
Model
G01552
Catalog number
DUCT9.5-100-P-FM
Device description
Connecting Tube Female to Male Luer Lock
Published
2017-08-22
Public version status
Update
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002015524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002015524008270020155248270020155240827002015524

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. 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
10841268110073Hemostasis Valve AdapterGALT MEDICAL CORP.DTL2026-01-19
10884450312459TRAM®PMerit Medical Systems, Inc.DTL2025-12-23
20197344137487NAMICMEDLINE INDUSTRIES, INC.DTL2025-11-28
10884450662301AccessPLUS™Merit Medical Systems, Inc.DTL2025-09-03
40884389862101MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-12
40884389734569MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-05
10197344100187NAMICMEDLINE INDUSTRIES, INC.DTL2025-08-04
00194613123406MSI Precision Specialty InstrumentsMed Saver, Inc.DTL2025-08-01
40884389734217MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734385MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734897MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734910MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734927MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734934MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734941MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875651MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875682MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40889942872801MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
10884450859718CPS H. Lee SafeSheath® Sealing AdapterMerit Medical Systems, Inc.DTL2025-05-31
30193489068218NAMICMEDLINE INDUSTRIES, INC.DTL2025-05-15
10884450860936PhD™Merit Medical Systems, Inc.DTL2025-05-13
20884450860971Honor®Merit Medical Systems, Inc.DTL2025-05-13
10884450003982PhD™Merit Medical Systems, Inc.DTL2025-04-23
10884450664213Honor®Merit Medical Systems, Inc.DTL2025-04-18
10884450860097AccessPLUS™Merit Medical Systems, Inc.DTL2025-03-28
2088445082130910Fore™Merit Medical Systems, Inc.DTL2025-03-15
20884450818101MBA™Merit Medical Systems, Inc.DTL2025-02-22
1088445083250610Fore™Merit Medical Systems, Inc.DTL2025-02-22
20884450834170Passage®Merit Medical Systems, Inc.DTL2025-02-06
10884450834166Passage®Merit Medical Systems, Inc.DTL2025-01-31