TriNav Infusion System

GUDID 00857136004217

120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

SUREFIRE MEDICAL, INC.

Peripheral vascular infusion catheter
Primary Device ID00857136004217
NIH Device Record Key1d63ecaf-a1b1-4ed8-b49a-6fa8467e3043
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriNav Infusion System
Version Model NumberTNV-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

Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter
Lumen/Inner Diameter0.021 Inch
Length120 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100857136004217 [Primary]

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


[00857136004217]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-09
Device Publish Date2020-01-01

On-Brand Devices [TriNav Infusion System]

00857136004217120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip
00857136004200150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

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