INTRODUCER SET VGHIS00

GUDID 00850004162163

VGHIS00 INTRODUCER SET

VALFLUX GROUP, LLC

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• Primary Device ID: 00850004162163
• NIH Device Record Key: a05dd434-f85f-479b-9a8f-79a6746670bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRODUCER SET
• Version Model Number: VGHIS00
• Catalog Number: VGHIS00
• Company DUNS: 050193715
• Company Name: VALFLUX GROUP, LLC
• 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: 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
• Phone: +556230916442
• Email: regulacao@valflux.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004162163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180178

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-12-20

On-Brand Devices [INTRODUCER SET]

• 00850004162200: VGHIS04 INTRODUCER SET
• 00850004162194: VGHIS03 INTRODUCER SET
• 00850004162187: VGHIS02 INTRODUCER SET
• 00850004162170: VGHIS01 INTRODUCER SET
• 00850004162163: VGHIS00 INTRODUCER SET
• 00850004162156: VGCTR04A INTRODUCER SET
• 00850004162149: VGCTR04 INTRODUCER SET
• 00850004162132: VGCTR03A INTRODUCER SET
• 00850004162125: VGCTR03 INTRODUCER SET