MANIFOLD VGAM0201

GUDID 00850004162019

VGAM0201 MANIFOLD

VALFLUX GROUP, LLC

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• Primary Device ID: 00850004162019
• NIH Device Record Key: dd36b32d-6e04-4c38-933f-a2e03fb2f174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANIFOLD
• Version Model Number: VGAM0201
• Catalog Number: VGAM0201
• Company DUNS: 050193715
• Company Name: VALFLUX GROUP, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br
• Phone: +556230916442
• Email: regulacao@valflux.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004162019 [Primary]

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

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: 2019-01-21
• Device Publish Date: 2018-12-19

On-Brand Devices [MANIFOLD]

• 00850004162033: VGAM0401 MANIFOLD
• 00850004162026: VGAM0301 MANIFOLD
• 00850004162019: VGAM0201 MANIFOLD