FDA.reportPublic FDA data

Cook

Primary DI
00827002020580
Brand
Cook
Company
COOK INCORPORATED
Model
G02058
Catalog number
C-PMS-401-FA
Device description
Femoral Artery Catheter Set
Published
2016-09-24
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002020580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002020580008270020205808270020205800827002020580

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood pressure catheterA sterile, thin flexible tube intended for short-term (<= 30 days) percutaneous placement within an artery for continuous blood pressure monitoring. It is typically interfaced with a parent device (e.g., external blood pressure transducer) and may be used for arterial blood sampling. The catheter is flushed between sampling procedures; it is not intended to be used for the administration of medication or fluids. Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire, adaptor) may be included. 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
10884450788407Impress®Merit Medical Systems, Inc.DQO2026-03-21
10884450787080Impress®Merit Medical Systems, Inc.DQO2026-03-19
50690103218607SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
10884450710729Impress®Merit Medical Systems, Inc.DQO2026-03-11
20841156111486LANGSTONTELEFLEX INCORPORATEDDQO2026-03-11
10884450787103Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450787455Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450788070Impress®Merit Medical Systems, Inc.DQO2026-02-19
10884450787653Impress®Merit Medical Systems, Inc.DQO2026-02-14
10884450852849Impress®Merit Medical Systems, Inc.DQO2026-02-14
50690103000417SWAN-GANZEdwards Lifesciences LLCDQO2026-01-30
00884450722329Impress®Merit Medical Systems, Inc.DQO2026-01-28
10884450787516Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450788124Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450787059Impress®Merit Medical Systems, Inc.DQO2026-01-22
10884450787837Impress®Merit Medical Systems, Inc.DQO2026-01-22
04987350744487DUALVIEWTERUMO CORPORATIONDQO2026-01-21
10884450787271Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787530Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450788797Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787721Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787745Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787707Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450787752Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450835934Performa®Merit Medical Systems, Inc.DQO2026-01-03
10884450787813Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787820Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450788650Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450787387Impress®Merit Medical Systems, Inc.DQO2025-12-20