Typenex Bacterial/Viral Filter

GUDID 10810050854471

Bacterial/Viral Filter

TYPENEX MEDICAL LLC

Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10810050854471
• NIH Device Record Key: 52311f97-94bb-409b-8b9d-ae2f648e3b56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Bacterial/Viral Filter
• Version Model Number: RE0301
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050854474 [Primary]
GS1	10810050854471 [Package]; Contains: 00810050854474; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033008

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-13
• Device Publish Date: 2022-04-05

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