FDA.reportPublic FDA data

ARROW

Primary DI
10801902191134
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919548
Catalog number
CDC-42552-JX1A
Device description
Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen JACC
Published
2021-11-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153423000CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-01-28LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902191131PackageGS13In Commercial Distribution
10801902191134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219113120801902191131
1080190219113410801902191134

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
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
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23
14026704945846RUSCH2214000602214000602026-07-23
20801902193548ARROWIPN920133CS-15362-SPM2026-07-23
20801902193593ARROWIPN920138CS-15192-VF2026-07-23
14026704927453GIBECKIPN929805133122025-07-31
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
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