FDA.reportPublic FDA data

Cook

Primary DI
00827002052673
Brand
Cook
Company
COOK INCORPORATED
Model
G05267
Catalog number
C-PLS-901
Device description
Peritoneal Lavage Set
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
GBWCATHETER, PERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002052673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002052673008270020526738270020526730827002052673

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter, acuteA tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane. It is usually percutaneously inserted for one-session dialysis in an acute setting. 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
50749756035243DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-08
50749756035755DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-03
20801902197942ARROWTELEFLEX INCORPORATEDGBW2022-11-09
10653405050032CORE DYNAMICSConmed CorporationGBW2022-06-02
04710961935865Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935872Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935889Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935896Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935902Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605810Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605827Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605759Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935858Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-11-24
14543527251959Super Sheath CBDETOGO MEDIKIT CO.,LTD.GBW2021-05-14
M368395310GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953120GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953140GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953340GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953580GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
00827002026254CookCOOK INCORPORATEDGBW2020-10-02
00827002043855CookCOOK INCORPORATEDGBW2020-10-02
00827002052680CookCOOK INCORPORATEDGBW2020-10-02
20801902162926ARROWTELEFLEX INCORPORATEDGBW2020-04-28
34026704656456TAUTTELEFLEX INCORPORATEDGBW2019-06-03
24026704656466TAUTTELEFLEX INCORPORATEDGBW2019-06-03
34026704656470TAUTTELEFLEX INCORPORATEDGBW2019-06-03
00801902005243ARROWTELEFLEX INCORPORATEDGBW2019-03-07
34026704656487TAUTTELEFLEX INCORPORATEDGBW2019-02-28
20801902121725ARROWTELEFLEX INCORPORATEDGBW2018-10-25
50885425501869CARDINAL HEALTHCardinal Health 200, LLCGBW2018-10-22