inFlow Intraurethral Valve-Pump https://gudid.fda.gov/gudid/app/admin/udi/recordDe

GUDID 08625630003027

Urinary prosthesis, female, non-surgical

VESIFLO INC

Intraurethral valve/pump
Primary Device ID08625630003027
NIH Device Record Key637e12dc-6418-4181-a175-5ba1189abf59
Commercial Distribution Discontinuation2020-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameinFlow Intraurethral Valve-Pump
Version Model NumberSep 2016
Catalog Numberhttps://gudid.fda.gov/gudid/app/admin/udi/recordDe
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter
Length30 Millimeter
Length35 Millimeter
Length40 Millimeter
Length45 Millimeter
Length50 Millimeter
Length55 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108625630003027 [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

[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


[08625630003027]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-31
Device Publish Date2016-12-07

On-Brand Devices [inFlow Intraurethral Valve-Pump]

08625630003027Urinary prosthesis, female, non-surgical
08625630003002Urinary prosthesis, female, non-surgical
08625630003034Urinary prosthesis, female, non-surgical -- Sizing Device
08625630003003Urinary prosthesis, female, non-surgical -- Sizing Device

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