FDA.reportPublic FDA data

ARROW

Primary DI
20801902145080
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN039276
Catalog number
EU-00755-45
Device description
Insertion Set for Arrow 5.5 Fr. PICCs
Published
2019-03-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080144000MANDREL GUIDEWIRES OR M-WIRESLake Region Mfg., Inc.2008-02-26DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902145080PackageGS15In Commercial Distribution
10801902145083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190214508020801902145080
1080190214508310801902145083

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902210897ARROWIPN925094ASK-21142-HF52026-08-04
10801902210903ARROWIPN925095ASK-21142-SG22026-08-04
10801902210934ARROWIPN925098ASK-21242-SL12026-08-04
10801902227116ARROWIPNB00557ASK-29903-CFV2026-08-31
10801902227208ARROWIPNB00556ASK-29803-CFV2026-08-31
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902227109ARROWIPNB00297ASK-09601-CF2026-09-03
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
10801902226065ARROWTELEFLEX INCORPORATEDDQX2026-05-08
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQX2026-02-24
00818075010233AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
10801902210637ARROWTELEFLEX INCORPORATEDDQX2023-06-21
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210583ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210590ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210613ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210620ARROWTELEFLEX INCORPORATEDDQX2023-06-06