FLOWMATE® INJKIT

GUDID 10801741067690

FLOWMATE® Injector Procedural Kit

Bard Peripheral Vascular, Inc.

Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit Angiography kit

• Primary Device ID: 10801741067690
• NIH Device Record Key: c19368f5-62ef-4e69-8f60-ea2faba7fe49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOWMATE®
• Version Model Number: INJKIT
• Catalog Number: INJKIT
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, 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: true
• 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: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741067693 [Primary]
GS1	10801741067690 [Package]; Contains: 00801741067693; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903390

FDA Product Code

• DXT: INJECTOR AND SYRINGE, ANGIOGRAPHIC

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: 2016-09-13

On-Brand Devices [FLOWMATE®]

• 10801741067690: FLOWMATE® Injector Procedural Kit
• 00801741067686: FLOWMATE® Injector