FDA.reportPublic FDA data

Synergy XS

Primary DI
00876604001237
Brand
Synergy XS
Company
Health Line International Corporation
Model
A14-04260-US
Device description
4Fr x 60cm Double Lumen Synergy XS CT PICC Basic Kit for US
Published
2016-11-17
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101329000SYNERGY CT PICCHealth Line International Corporation2010-08-19LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10876604001234PackageGS15In Commercial Distribution
20876604001231PackageGS14In Commercial Distribution
00876604001237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087660400123410876604001234
2087660400123120876604001231
00876604001237008766040012378766040012370876604001237

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA 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.

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
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3R0031C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S900C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9150C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S920C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9220C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S930C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S940C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S950C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S970C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H965458160BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H965458560BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H96560M13031150BioFloNAVILYST MEDICAL, INC.LJS2021-06-24
H96560M13031130BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M13031160BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14