Aerobiotix

GUDID 00852348007551

Air purification machine

AEROBIOTIX, INC.

Surgical laminar airflow unit

• Primary Device ID: 00852348007551
• NIH Device Record Key: 3f47d686-bb4d-44a1-b5c1-26034ad7e81b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerobiotix
• Version Model Number: AeroCure Vac
• Company DUNS: 046659903
• Company Name: AEROBIOTIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com
• Phone: 888-978-7087
• Email: sales@aerobiotix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852348007551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203189

FDA Product Code

• FRA: Purifier, Air, Ultraviolet, Medical

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: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Aerobiotix]

• 00852348007551: Air purification machine
• 00852348007445: Air purification pre-filter
• 00852348007568: Air purification HEPA Carbon Filter
• 00852348007452: Sterile air purification pre-filter
• 00852348007773: Air purification machine
• 00852348007582: Air purification ULPA Carbon F Filter Assembly
• 00852348007438: Air purification machine vac hose
• 00852348007193: Air purification machine vac intake foot pedal
• 00852348007186: Air purification machine vac intake hose
• 00852348007179: Air purification ULPA filter cartridge
• 00852348007155: Air purification machine