Activator 403300

GUDID 00862563003153

Magnetic remote control for the inFlow Device

VESIFLO INC

Intraurethral valve/pump

• Primary Device ID: 00862563003153
• NIH Device Record Key: fae15ece-a864-4deb-9dd3-817f5e2dbf89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activator
• Version Model Number: August 2021
• Catalog Number: 403300
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862563003153 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-06
• Device Publish Date: 2021-08-28

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