ARROW CU-13122-F

GUDID 20801902096702

You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions

TELEFLEX INCORPORATED

Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable Double-lumen haemodialysis catheter, nonimplantable
Primary Device ID20801902096702
NIH Device Record Key9114dc22-f913-47e6-b81a-a9c44c0cbd5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameARROW
Version Model NumberIPN030206
Catalog NumberCU-13122-F
Company DUNS002348191
Company NameTELEFLEX INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS110801902096705 [Primary]
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution
GS120801902096702 [Package]
Contains: 10801902096705
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted
MPBCatheter, hemodialysis, non-implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [ARROW]

00801902136749RediGuard IAB: 7Fr 30cc
00801902136732RediGuard IAB: 8Fr 40cc
00801902136725FiberOptix Ultra 8 IAB: 8Fr 30cc
00801902136718FiberOptix Ultra 8 IAB: 8Fr 40cc
00801902136701UltraFlex IAB: 7.5Fr 30cc
00801902136695UltraFlex IAB: 7.5Fr 40cc
30801902111549Arrow(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
30801902111532Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
30801902111525Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902111471Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
30801902111464Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
30801902111457Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
30801902111440Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology
30801902111433Peritoneal Lavage Kit
30801902111426Maximal Barrier Drape
30801902111402Arrow-Howes(TM) Quad-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWg+ard Bl
30801902111365Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter
30801902111334Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
30801902111327Arterial Catheterization Kit
30801902111310Radial Artery Catheterization Kit
30801902111303Arterial Catheterization Kit
30801902109591Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
30801902109584Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902109577Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen Central Venous Catheterization Kit
10801902109559NextStep(R) Antegrade Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to
30801902109546Edge(R) Hemodialysis Catheterization Set Long-Term Access Catheter Length, Cuff to Tip: 31 cm
30801902109539Spring Wire Guide Kit
30801902109522Arterial Line Kit
30801902109515Arterial Catheterization Kit
1080190210950415 Fr. x 19 cm NextStep(R) Antegrade Hemodialysis Catheterization Set, Long-Term Access Catheter
30801902109485Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen Central Venous Catheterization Kit
30801902109478Arterial Line Kit with Sharps Safety Features
30801902109461ARROWg+ard Blue(R) PSI Kit for use with 7.5 - 8 Fr. Catheters
30801902109454Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902109447Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
30801902109430Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902109423ARROWg+ard Blue(R) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheter
30801902109416Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902109409Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
30801902109218Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters
30801902108464Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902108419Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902108396Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902108358Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902108327Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902106668Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
30801902105456Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902105449Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902105401Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
30801902105333Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter

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