Surefire Infusion System

GUDID 00857136004019

120cm, 3.8F Microcatheter with 7.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter
Primary Device ID00857136004019
NIH Device Record Key2f1692d6-cafe-449a-af3f-a4ef9fa62fd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurefire Infusion System
Version Model NumberSHF-38120-LT
Company DUNS832575497
Company NameSUREFIRE MEDICAL, INC.
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length120 Centimeter
Length120 Centimeter
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter
Lumen/Inner Diameter0.027 Inch
Outer Diameter0.051 Inch
Length120 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100857136004019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


[00857136004019]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-09
Device Publish Date2016-09-08

On-Brand Devices [Surefire Infusion System]

00857136004040120cm, 3.8F Microcatheter with 5mm Expandable Tip
00857136004019120cm, 3.8F Microcatheter with 7.5mm Expandable Tip

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