Procedure Products, Inc.

GUDID B16080391

Large Catheter Adapter

PROCEDURE PRODUCTS, INC.

General-purpose catheter connector, sterile General-purpose catheter connector, sterile

• Primary Device ID: B16080391
• NIH Device Record Key: 4decb7db-9ff0-4526-b911-d4c7bfd92bae
• Commercial Distribution Discontinuation: 2018-12-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Procedure Products, Inc.
• Version Model Number: 8039
• 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

Customer Support Contacts

• Phone: 360 693 1832
• Email: doug@procedureproducts.com
• Phone: 360 693 1832
• Email: doug@procedureproducts.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B16080391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810921

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-03
• Device Publish Date: 2016-12-01

Devices Manufactured by PROCEDURE PRODUCTS, INC.

• B1601006B1 - Freedom Syringe: 2020-09-08 Freedom Syringe, 6cc Blue Plunger
• B160B10R0721 - Procedure Products Lines: 2020-05-01 HIGH PRESSURE BRAIDED SWIVEL LINE, 10"
• B1601001R1 - Freedom Syringe: 2020-03-18 Freedom Syringe, 01cc Red Plunger
• B1601003G1 - Freedom Syringe: 2020-03-18 Freedom Syringe, 03cc Green Plunger
• B1601010B1 - Freedom Syringe: 2020-03-18 Freedom Syringe, 10cc Blue Plunger
• B1601020W1 - Freedom Syringe: 2020-03-18 Freedom Syringe, 20cc White Plunger
• B1603118451 - Procedure Products Needle: 2020-03-18 NEEDLE, W/O BASEPLATE, 11CM 18g
• B1605320Y1 - Procedure Products Syringe: 2019-10-10 10CC PALM PAD CONTROL SYRINGE, Yellow Plunger