FDA.reportPublic FDA data

Activator Kit

Primary DI
00862563003184
Brand
Activator Kit
Company
VESIFLO INC
Model
August 2021
Catalog number
403507K
Device description
Magnetic remote control for the inFlow Device - with base station and medical charger
Published
2021-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PIHUrethral Insert With Pump For Bladder Drainage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIHUrethral Insert With Pump For Bladder DrainageGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130044000INFLOW INTRAURETHRAL VALVE-PUMPVesiflo, Inc.2014-10-14PIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862563003184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862563003184008625630031848625630031840862563003184

GMDN Terms#

Term, Definition table
TermDefinition
Intraurethral valve/pumpA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005928578
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862563003078inFlow Sizing DeviceMarch 2017203511-SD2021-08-28
00862563003085inFlow DeviceMarch 2017203511-302021-08-28
00862563003092inFlow DeviceMarch 2017203511-352021-08-28
00862563003108inFlow DeviceMarch 2017203511-402021-08-28
00862563003115inFlow DeviceMarch 2017203511-452021-08-28
00862563003122inFlow DeviceMarch 2017203511-502021-08-28
00862563003139inFlow DeviceMarch 2017203511-552021-08-28
00862563003146inFlow DeviceMarch 2017203511-602021-08-28
00862563003153ActivatorAugust 20214033002021-08-28
00862563003160Base StationAugust 20214033102021-08-28
00862563003177Medical ChargerAugust 20214033202021-08-28
00862563003191Magnetic ShieldAugust 20214033502021-08-28
08625630003003inFlow Intraurethral Valve-PumpSep 2016203511 SD2016-10-24
08625630003034inFlow Intraurethral Valve-PumpSep 2016203511 SD2016-12-07
08625630003001ActivatorSep 20164035072016-09-19
08625630003002inFlow Intraurethral Valve-PumpSep 20162035112016-09-20
08625630003010ActivatorSep 20164035072016-12-08
08625630003027inFlow Intraurethral Valve-PumpSep 2016https://gudid.fda.gov/gudid/app/admin/udi/recordDe2016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862563003078inFlow Sizing DeviceVESIFLO INCPIH2021-08-28
00862563003085inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003092inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003108inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003115inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003122inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003139inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003146inFlow DeviceVESIFLO INCPIH2021-08-28
00862563003153ActivatorVESIFLO INCPIH2021-08-28
00862563003160Base StationVESIFLO INCPIH2021-08-28
00862563003177Medical ChargerVESIFLO INCPIH2021-08-28
00862563003191Magnetic ShieldVESIFLO INCPIH2021-08-28
08625630003010ActivatorVESIFLO INCPIH2016-12-08
08625630003034inFlow Intraurethral Valve-PumpVESIFLO INCPIH2016-12-07
08625630003027inFlow Intraurethral Valve-PumpVESIFLO INCPIH2016-12-07
08625630003003inFlow Intraurethral Valve-PumpVESIFLO INCPIH2016-10-24
08625630003002inFlow Intraurethral Valve-PumpVESIFLO INCPIH2016-09-20
08625630003001ActivatorVESIFLO INCPIH2016-09-19