inFlow Sizing Device 203511-SD

GUDID 00862563003078

Urethral measurement device, female.

VESIFLO INC

Intraurethral valve/pump

• Primary Device ID: 00862563003078
• NIH Device Record Key: 4896fa85-1ef1-402a-b572-ccf0cebe806f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inFlow Sizing Device
• Version Model Number: March 2017
• Catalog Number: 203511-SD
• Company DUNS: 005928578
• Company Name: VESIFLO INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00862563003078 [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: true
• Device Is Sterile: true

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

[00862563003078]

Radiation Sterilization

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: 2021-09-06Urethral measurement device, female.
• 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