FDA.report

Cook

Primary DI
00827002019232
Brand
Cook
Company
COOK INCORPORATED
Model
G01923
Catalog number
C-PMSY-300-RA
Device description
Radial Artery Catheter Tray Polyethylene Catheter
Published
2016-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002019232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002019232008270020192328270020192320827002019232

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

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
true
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 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 DIBrandCompanyProduct codePublished
30841156103983SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156103993SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104006SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104013SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104020SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104037SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104044SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
30841156104058SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
20801902225256ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225263ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225270ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225287ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20841156103887TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103894TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103914TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103931TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103952TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
00763000747459NAMEDTRONIC, INC.DQY2026-02-09
00763000747466NAMEDTRONIC, INC.DQY2026-02-09
00763000747473NAMEDTRONIC, INC.DQY2026-02-09
00763000747480NAMEDTRONIC, INC.DQY2026-02-09
04547327165563ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165570ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165587ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165594ASAHI Veloute C3ASAHI INTECC CO., LTD.DQY2026-02-05