Typenex Heat and Moisture Exchanger with Filter

GUDID 10810050854433

Heat and Moisture Exchanger with Filter (Small)

TYPENEX MEDICAL LLC

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• Primary Device ID: 10810050854433
• NIH Device Record Key: 24871339-693b-4019-a580-8cfa51e5a5e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Heat and Moisture Exchanger with Filter
• Version Model Number: RE0101
• 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	00810050854436 [Primary]
GS1	10810050854433 [Package]; Contains: 00810050854436; 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

On-Brand Devices [Typenex Heat and Moisture Exchanger with Filter]

• 10810050854440: Heat and Moisture Exchanger with Filter (Large)
• 10810050854433: Heat and Moisture Exchanger with Filter (Small)