HME Filter

GUDID 00819989014928

Heat Moisture Exchanger, O2 configuration

EXCELERON MEDICAL, INC.

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 00819989014928
• NIH Device Record Key: 813c9f3a-5446-41fd-ad61-68504a48a1ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HME Filter
• Version Model Number: HME-T-O2
• Company DUNS: 825179992
• Company Name: EXCELERON MEDICAL, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819989014928 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-05
• Device Publish Date: 2021-07-28

On-Brand Devices [HME Filter]

• 00819989014911: Heat Moisture Exchanger, T configuration
• 00819989014928: Heat Moisture Exchanger, O2 configuration