FDA.reportPublic FDA data

Cook Spectrum Turbo-Ject

Primary DI
00827002237087
Brand
Cook Spectrum Turbo-Ject
Company
COOK INCORPORATED
Model
G23708
Catalog number
UPICS-4.0-CT-40NT-ABRM-1110
Device description
Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter
Published
2015-10-24
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002237087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002237087008270022370878270022370870827002237087

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). 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
Combination product
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
10801741239356PowerPICC Sherlock 3CGBard Access Systems, Inc.LJS2026-03-11
10801741239363PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
10801741239370PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908152703PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154714PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154721PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160234PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160258PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908174361PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184117VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184124VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184278VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184285VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184292VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184308VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184315VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184322VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
10801741238830PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-02-11
50884908062415VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062446VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062477VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062729VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062804MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31
50884908062811MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31