Surefire Precision Infusion System

GUDID 00857136004088

120cm, 0.021" Microcatheter with 3.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter
Primary Device ID00857136004088
NIH Device Record Keya2459642-842c-44b2-b20c-722bdbb42e71
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurefire Precision Infusion System
Version Model NumberSPS-21120-35
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

Catheter Gauge3.2 French
Catheter Gauge3.2 French
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Catheter Gauge3.2 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100857136004088 [Primary]

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


[00857136004088]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-09-08

On-Brand Devices [Surefire Precision Infusion System]

00857136004132150cm 0.025" Microcatheter w/ 5mm Expandable Tip
00857136004125150cm 0.025" Microcatheter w/ 7mm Expandable Tip
00857136004118120cm 0.025" Microcatheter w/ 7mm Expandable Tip
00857136004101120cm 0.025" Microcatheter w/ 5mm Expandable Tip
00857136004095150cm 0.021" Microcatheter w/ 3.5mm Expandable Tip
00857136004088120cm, 0.021" Microcatheter with 3.5mm Expandable Tip

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