InHealth Technologies; Blom-Singer; ClassicFlow

GUDID 00848253002996

Freudenberg Medical, LLC

Heat/moisture exchanger, single-use

• Primary Device ID: 00848253002996
• NIH Device Record Key: 49e53dcd-94c0-4739-8489-825527828fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InHealth Technologies; Blom-Singer; ClassicFlow
• Version Model Number: HME Cartridge ClassicFlow
• Company DUNS: 120981337
• Company Name: Freudenberg Medical, LLC
• Device Count: 6
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848253002613 [Previous]
GS1	00848253002989 [Unit of Use]
GS1	00848253002996 [Primary]
GS1	00848253003009 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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: 2020-03-26
• Device Publish Date: 2017-12-31

On-Brand Devices [InHealth Technologies; Blom-Singer; ClassicFlow]

• 00848253003153: BE 1055EZ6
• 00848253003009: HME Cartridge ClassicFlow
• 00848253002996: HME Cartridge ClassicFlow