ARROW CSD-15362-I

GUDID 40801902096669

15 Fr. 36 cm Edge(R) Hemodialysis CatheterizationSet, Long-Term Access Catheter Length, Cuff to Tip: 31 cm

TELEFLEX INCORPORATED

Double-lumen haemodialysis catheter, implantable
Primary Device ID40801902096669
NIH Device Record Key5b650a50-3732-468c-b166-b06b9b357ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameARROW
Version Model NumberIPN033114
Catalog NumberCSD-15362-I
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
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
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
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
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
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 Dimensions

Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter
Catheter Gauge15 French
Length31 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110801902096668 [Primary]
GS120801902096665 [Package]
Package: Case [1 Units]
In Commercial Distribution
GS140801902096669 [Package]
Contains: 10801902096668
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSDCatheter, hemodialysis, implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2018-06-26

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

Trademark Results [ARROW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARROW
ARROW
98785439 not registered Live/Pending
Quad-States Industries, Inc.
2024-10-04
ARROW
ARROW
98784387 not registered Live/Pending
Quad-States Industries, Inc.
2024-10-03
ARROW
ARROW
98699043 not registered Live/Pending
Tatom, David
2024-08-14
ARROW
ARROW
98415956 not registered Live/Pending
Arrow Investment Analytics, LLC
2024-02-22
ARROW
ARROW
98408806 not registered Live/Pending
Southern California Regional Rail Authority ("SCRRA")
2024-02-16
ARROW
ARROW
98387940 not registered Live/Pending
ARROW FASTENER CO.,LLC
2024-02-02
ARROW
ARROW
98235609 not registered Live/Pending
Arrow Interactive LLC
2023-10-23
ARROW
ARROW
98207717 not registered Live/Pending
Maison Battat, Inc.
2023-10-03
ARROW
ARROW
98109825 not registered Live/Pending
ASSA ABLOY Access and Egress Hardware Group, Inc.
2023-07-31
ARROW
ARROW
98109821 not registered Live/Pending
ASSA ABLOY Access and Egress Hardware Group, Inc.
2023-07-31
ARROW
ARROW
98109533 not registered Live/Pending
ASSA ABLOY Access and Egress Hardware Group, Inc.
2023-07-31
ARROW
ARROW
97926781 not registered Live/Pending
Blake Bigot
2023-05-09

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