inFlow Device 203511-60

GUDID 00862563003146

Intraurethral Valve-Pump

VESIFLO INC

Intraurethral valve/pump
Primary Device ID00862563003146
NIH Device Record Key0a136adb-70d4-4ed6-a18a-690e0b170b82
Commercial Distribution StatusIn Commercial Distribution
Brand NameinFlow Device
Version Model NumberMarch 2017
Catalog Number203511-60
Company DUNS005928578
Company NameVESIFLO INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100862563003146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIHUrethral Insert With Pump For Bladder Drainage

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


[00862563003146]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-28

On-Brand Devices [inFlow Device]

00862563003146Intraurethral Valve-Pump
00862563003139Intraurethral Valve-Pump
00862563003122Intraurethral Valve-Pump
00862563003115Intraurethral Valve-Pump
00862563003108Intraurethral Valve-Pump
00862563003092Intraurethral Valve-Pump
00862563003085Intraurethral Valve-Pump

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