Aero-Sat Filter Pedi

GUDID 10841470110458

PULMODYNE INC

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

• Primary Device ID: 10841470110458
• NIH Device Record Key: d4fb66a7-8892-4cc2-9daa-2cb49168f025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Sat Filter Pedi
• Version Model Number: 101002
• Company DUNS: 030619483
• Company Name: PULMODYNE INC
• 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: 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	00841470110451 [Primary]
GS1	10841470110458 [Package]; Contains: 00841470110451; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013122

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: 2022-04-04
• 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