Activator Kit 403507K

GUDID 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger

VESIFLO INC

Intraurethral valve/pump

• Primary Device ID: 00862563003184
• NIH Device Record Key: a1e8f8a2-6948-43b3-81b5-8e31d19dec43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activator Kit
• Version Model Number: August 2021
• Catalog Number: 403507K
• 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: true
• 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	00862563003184 [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

Devices Manufactured by VESIFLO INC

• 00862563003078 - inFlow Sizing Device: 2021-09-06 Urethral measurement device, female.
• 00862563003085 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003092 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003108 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003115 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003122 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003139 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump
• 00862563003146 - inFlow Device: 2021-09-06 Intraurethral Valve-Pump