FLOWMATE® INJKIT

GUDID 10801741067690

FLOWMATE® Injector Procedural Kit

Bard Peripheral Vascular, Inc.

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