ARROW AI-07130-J

GUDID 20801902160687

5 Fr. 60 cm Berman Angiographic Balloon Catheter

TELEFLEX INCORPORATED

Angiographic catheter, single-use Angiographic catheter, single-use
Primary Device ID20801902160687
NIH Device Record Key82d582d0-4175-430f-a211-0c6c19e25db9
Commercial Distribution StatusIn Commercial Distribution
Brand NameARROW
Version Model NumberIPN915293
Catalog NumberAI-07130-J
Company DUNS002348191
Company NameTELEFLEX INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon.

Device Identifiers

Device Issuing AgencyDevice ID
GS110801902160680 [Primary]
GS110801902160680 [Primary]
GS120801902160687 [Package]
Contains: 10801902160680
Package: Case [5 Units]
In Commercial Distribution
GS120801902160687 [Package]
Contains: 10801902160680
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYGCATHETER, FLOW DIRECTED
DYGCATHETER, FLOW DIRECTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2019-12-19

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30801902111549Arrow(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
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30801902111471Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
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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
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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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