Freedom Syringe

GUDID B1601010B1

Freedom Syringe, 10cc Blue Plunger

PROCEDURE PRODUCTS, INC.

General-purpose syringe, single-use

• Primary Device ID: B1601010B1
• NIH Device Record Key: 23955448-2590-4e55-8e93-53ccb8ce1b39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Syringe
• Version Model Number: 1010-B
• 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	B1601010B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161812

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

On-Brand Devices [Freedom Syringe]

• B1601020W1: Freedom Syringe, 20cc White Plunger
• B1601010B1: Freedom Syringe, 10cc Blue Plunger
• B1601003G1: Freedom Syringe, 03cc Green Plunger
• B1601001R1: Freedom Syringe, 01cc Red Plunger
• B1601006B1: Freedom Syringe, 6cc Blue Plunger