Aero-T

GUDID 10841470109926

PULMODYNE INC

Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use

• Primary Device ID: 10841470109926
• NIH Device Record Key: 9d3278c4-e33f-411e-b94d-9653ea005b33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-T
• Version Model Number: 300102
• Company DUNS: 030619483
• Company Name: PULMODYNE 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: false
• Expiration Date: true
• 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	00841470109929 [Primary]
GS1	10841470109926 [Package]; Contains: 00841470109929; Package: [30 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-04
• Device Publish Date: 2022-03-25

Devices Manufactured by PULMODYNE INC

• 10841470100718 - VT Select: 2023-04-18
• 10841470100749 - VT Select: 2023-04-18
• 10841470100770 - VT Select: 2023-04-18
• 10841470100794 - VT Select: 2023-04-18
• 10841470100817 - VT Select: 2023-04-18
• 10841470106505 - BiTrac SE Select: 2022-04-05
• 10841470100282 - DART: 2022-04-04
• 10841470100299 - DART: 2022-04-04