VixOne™ Nebulizer Kit R-6400

GUDID 50628725097478

NEBULIZER VIXONE

Canadian Hospital Specialties Limited

Benchtop nebulizer, non-heated

• Primary Device ID: 50628725097478
• NIH Device Record Key: 9f1c5a55-54f0-4f57-9e86-cc38bae72c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VixOne™ Nebulizer Kit
• Version Model Number: R-6400
• Catalog Number: R-6400
• Company DUNS: 240992693
• Company Name: Canadian Hospital Specialties Limited
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com
• Phone: 905-825 9300
• Email: regulatory.affairs@chsltd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628725098173 [Primary]
GS1	50628725097478 [Package]; Contains: 00628725098173; Package: Corrugate Case [50 Units]; In Commercial Distribution

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-06-15

On-Brand Devices [VixOne™ Nebulizer Kit]

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• 50628725098239: NEBULIZER VIXONE ADULT AEROSOL MASK 7' SAFLO OXYGEN TUBING
• 50628725098215: NEBULIZER VIXONE T PIECE MOUTHPIECE 7' SAFLO TUBING 6' CORRUGATED TUBING
• 50628725097478: NEBULIZER VIXONE
• 50628725098208: UP-DRAFT BOTTOM CONNECTION NEBULIZER VIXONE WITH 7ft SAFLO