Activator 403507

GUDID 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.

VESIFLO INC

Intraurethral valve/pump

• Primary Device ID: 08625630003001
• NIH Device Record Key: ee0f3b62-f411-4f10-8e67-239ddf0e7aa2
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Activator
• Version Model Number: Sep 2016
• Catalog Number: 403507
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08625630003001 [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: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-31
• Device Publish Date: 2016-09-19

On-Brand Devices [Activator]

• 08625630003010: Magnetic remote control for operation of inFlow urinary prosthesis. With base station and rechar
• 08625630003001: Magnetic remote control for operation of inFlow urinary prosthesis. With base station and rechar
• 00862563003153: Magnetic remote control for the inFlow Device