Procedure Products Line MF-12LB

GUDID B160MF12LB1

Pressure Injection Line, 12", male & female

PROCEDURE PRODUCTS, INC.

Intravenous line recessed-needle connector Intravenous line recessed-needle connector

• Primary Device ID: B160MF12LB1
• NIH Device Record Key: 7f3f066c-b798-46b8-b91d-9286b1904f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Line
• Version Model Number: MF-12LB
• Catalog Number: MF-12LB
• Company DUNS: 151507563
• Company Name: PROCEDURE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	B160MF12LB1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914128

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-02

On-Brand Devices [Procedure Products Line]

• B160MF481: Pressure Line, 48", Male & Female
• B160MF12LB1: Pressure Injection Line, 12", male & female