FDA.report

Cook Spectrum

Primary DI
00827002247604
Brand
Cook Spectrum
Company
COOK INCORPORATED
Model
G24760
Catalog number
C-UDLM-501J-LSC-ABRM-HC-CAH
Device description
Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Double Lumen Polyurethane
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

Product Codes

CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002247604PrimaryGS10

GMDN Terms

TermDefinition
Central venous catheterA sterile, flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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
false
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
20801902219385ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30801902219405ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219415ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219460ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219484ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219514ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30197344181517MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344181527MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344199690MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20801902225478ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225485ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225492ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225539ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
30801902219375ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219392ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219422ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219439ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219446ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219453ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219477ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219491ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219507ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219521ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219538ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219545ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219569ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219576ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219583ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219590ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
30382903836483NexivaBECTON, DICKINSON AND COMPANYFOZ2026-02-17