AccessGUDID - DEVICE: inFlow Intraurethral Valve-Pump (08625630003002)

GUDID

Device Identifier (DI) Information

Brand Name: inFlow Intraurethral Valve-Pump
Version or Model: Sep 2016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 203511
Company Name: VESIFLO INC

Primary DI Number: 08625630003002
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005928578 *Terms of Use

Device Description: Urinary prosthesis, female, non-surgical

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62305	Intraurethral valve/pump	A sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. It is a tube, held in place at the bladder neck, containing a pump and valve. Its function as a pump to achieve urinary voiding, and as a valve to prevent urine leakage (incontinence) between voids, is controlled by a battery-powered, magnetically-coupled remote control. This is a single-patient device intended to be left in situ for up to 29 days before being discarded (single-use) and replaced.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIH	Urethral Insert With Pump For Bladder Drainage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN130044	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter
Length: 55 Millimeter
Length: 50 Millimeter
Length: 45 Millimeter
Length: 40 Millimeter
Length: 35 Millimeter
Length: 30 Millimeter

Device Record Status

Public Device Record Key: 61b658fc-189b-4123-a69c-9f04ce5bd678
Public Version Date: December 31, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016