BioFlo

GUDID B567AU170

BioFlo AutoValve Urine Valve

INSERT MOLDING SOLUTIONS INC

Urethral/suprapubic catheter valve-connector Urethral/suprapubic catheter valve-connector

• Primary Device ID: B567AU170
• NIH Device Record Key: 9f65ac46-43c7-49ae-a764-5b567b759434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFlo
• Version Model Number: AU17
• Company DUNS: 031736504
• Company Name: INSERT MOLDING SOLUTIONS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B567AU170 [Primary]
HIBCC	B567AU171 [Package]; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• FCN: Urinary Drainage Collection Kit, For Indwelling Catheter

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B567AU170]

Ethylene Oxide

[B567AU170]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-08

Devices Manufactured by INSERT MOLDING SOLUTIONS INC

• B567AU170 - BioFlo: 2019-03-11BioFlo AutoValve Urine Valve
• B567AU170 - BioFlo: 2019-03-11 BioFlo AutoValve Urine Valve
• B567MC18200 - M Core: 2019-03-11 Biopsy Needle
• B567MC18250 - M-Core: 2019-03-11 Disposable Core Biopsy Needle