FDA.reportPublic FDA data

Health Line

Primary DI
00876604000445
Brand
Health Line
Company
Health Line International Corporation
Model
KIT-420-42
Device description
Health Line 4F x 10cm Double Lumen CT Midline Kit
Published
2016-11-10
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

Product Codes#

Code, Name table
CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10876604000442PackageGS15In Commercial Distribution
20876604000449PackageGS14In Commercial Distribution
00876604000445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087660400044210876604000442
2087660400044920876604000449
00876604000445008766040004458766040004450876604000445

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806251398
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00876604004603Synergy-XSA14-03160-03A14-031602023-05-24
00876604004627Synergy-XSA14-04260-03A14-042602023-05-24
00876604004634SynergyA14-05160-03A14-051602023-05-24
00876604004641SynergyA14-05260-03A14-052602023-05-24
00876604004658SynergyA14-06260-03A14-062602023-05-24
00876604004665SynergyA14-06360-03A14-063602023-05-24
00876604004672Synergy-XSA14-03160-N-03A14-03160-N2023-05-24
00876604004689Synergy-XSA14-04260-N-03A14-04260-N2023-05-24
00876604004696SynergyA14-05160-N-03A14-05160-N2023-05-24
00876604004702SynergyA14-06260-N-03A14-06260-N2023-05-24
00876604004719SynergyA14-06360-N-03A14-06360-N2023-05-24
00876604004726SynergyA14-05260-N-03A14-05260-N2023-05-24
00876604004733SynergyA14-04160-N-03A14-04160-N2023-05-24
00876604004740Synergy-XSA14-03160-IR-03A14-03160-IR2023-05-24
00876604004757SynergyA14-04160-IR-03A14-04160-IR2023-05-24
00876604004764Synergy-XSA14-04260-IR-03A14-04260-IR2023-05-24
00876604004788SynergyA14-05260-IR-03A14-05260-IR2023-05-24
00876604004795SynergyA14-06260-IR-03A14-06260-IR2023-05-24
00876604004801SynergyA14-06360-IR-03A14-06360-IR2023-05-24
10876604004600Synergy-XSA14-03160-03A14-031602023-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26