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 ID	08625630003027
NIH Device Record Key	637e12dc-6418-4181-a175-5ba1189abf59
Commercial Distribution Discontinuation	2020-12-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	inFlow Intraurethral Valve-Pump
Version Model Number	Sep 2016
Catalog Number	https://gudid.fda.gov/gudid/app/admin/udi/recordDe
Company DUNS	005928578
Company Name	VESIFLO INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter
Length	30 Millimeter
Length	35 Millimeter
Length	40 Millimeter
Length	45 Millimeter
Length	50 Millimeter
Length	55 Millimeter
Length	60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08625630003027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

deNovo: DEN130044

FDA Product Code

PIH	Urethral Insert With Pump For Bladder Drainage

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[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 Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-12-31
Device Publish Date	2016-12-07

On-Brand Devices [inFlow Intraurethral Valve-Pump]

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