Aero-Sat Filter Compact Straight

GUDID 10841470110489

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10841470110489
• NIH Device Record Key: 4ce4ebd9-4698-425e-85ce-0d2b821cc003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero-Sat Filter Compact Straight
• Version Model Number: 100801
• 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	00841470110482 [Primary]
GS1	10841470110489 [Package]; Contains: 00841470110482; Package: [25 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: true

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

On-Brand Devices [Aero-Sat Filter Compact Straight]

• 10841470110489: 100801
• 10841470110472: 100802