Hepa-Care®

GUDID 00818261021005

Hepa-Care® Portable Unit, 120 VAC, 2 Amp, 60 Hz. Electrical safety: UL 1598:2008/R:2012-10 & CSA C22.2 No. 250.0:2008/R2013-10. Mechanical Safety: UL 1598:2008/R:2012-10 & CSA C22.2 No. 250.0:2008/R2013-10. Made in Canada

ABATEMENT TECHNOLOGIES, INC.

Ultraviolet germicidal light

• Primary Device ID: 00818261021005
• NIH Device Record Key: 28ba1cb2-e876-4f30-9977-81828974e56b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hepa-Care®
• Version Model Number: UV800F
• Company DUNS: 173503806
• Company Name: ABATEMENT TECHNOLOGIES, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com
• Phone: 18006349091
• Email: iaqinfo@abatement.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818261021005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984116

FDA Product Code

• FRF: Cleaner, Air, Medical Recirculating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-11

On-Brand Devices [Hepa-Care®]

• 00818261021036: Hepa-Care® Ceiling Unit, 120 VAC, 2 Amp, 60 Hz. Electrical safety: UL 1598:2008/R:2012-10 & CSA
• 00818261021012: Hepa-Care® Ceiling Unit, 120 VAC, 2 Amp, 60 Hz. Electrical safety: UL 1598:2008/R:2012-10 & CSA
• 00818261021005: Hepa-Care® Portable Unit, 120 VAC, 2 Amp, 60 Hz. Electrical safety: UL 1598:2008/R:2012-10 & CS
• 00818261020916: Hepa-Care® Ceiling Unit, 220-240 Volt 2 Amp 50 Hz. Motor thermally protected single phase. Made
• 00818261020909: Hepa-Care® Ceiling Unit, 115 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. Electr
• 00818261020893: Hepa-Care® Portable Unit, 220-240 Volt 3.5 amps 50 Hz ULPA filter. Motor thermally protected si
• 00818261020817: Hepa-Care® Portable Unit, 220-240 Volt, 3.5 amp, 50 Hz. Motor thermally protected single phase.
• 00818261020800: Hepa-Care® Portable Unit, 115 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. Elect
• 00818261020640: Hepa-Care® Portable Unit, 220-240 Volt 2 Amp 60 Hz G plug. Motor thermally protected single pha
• 00818261020619: Hepa-Care® Portable Unit, 220-240 Volt 2 Amp 50 Hz. Motor thermally protected single phase. Mad
• 00818261020602: Hepa-Care® Portable Unit, 120 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. Elect
• 00818261020534: Hepa-Care® Portable Unit, 220-240 Volt 2 Amp 50 Hz G plug. Motor thermally protected single pha
• 00818261020510: Hepa-Care® Portable Unit, 220-240 Volt 1.5 Amp 50 Hz. Motor thermally protected single phase. M
• 00818261020503: Hepa-Care® Portable Unit, 120 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. Elect
• 00818261020312: Hepa-Care® Portable Unit, 220-240 Volt 1 Amp 50 Hz. Motor thermally protected single phase. Mad
• 00818261020305: Hepa-Care® Portable Unit, 115 Volt, 2.5 Amp, 60 Hz. Motor thermally protected single phase. Ele
• 00818261020206: Hepa-Care® Portable Unit, 115 Volt 2.5 Amp 60 Hz. Motor thermally protected single phase. Elect
• 00818261022606: HEPA-CARE® Digital Ceiling Unit, 120 Volt, 3.25 Amp, 60 Hz. Motor thermally protected, single p
• 00818261022309: HEPA-CARE® Digital Portable Unit with UV, 120 Volt, 3.5 Amp, 60 Hz. Motor thermally protected,
• 00818261022002: HEPA-CARE® Digital Portable Unit, 120 Volt, 3.5 Amp, 60 Hz. Motor thermally protected, single p
• 00818261021708: HEPA-CARE® Digital Ceiling Unit, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single phas
• 00818261021401: HEPA-CARE® Digital Portable Unit with UV, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, si
• 00818261021104: HEPA-CARE® Digital Portable Unit, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single pha
• 00818261023504: HEPA-CARE® Digital Ceiling Unit, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single phas
• 00818261023207: HEPA-CARE® Digital Portable Unit with UV, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, si
• 00818261022903: HEPA-CARE® Digital Portable Unit, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single pha
• 00818261022019: HEPA-CARE® Digital Portable Unit, 230 Volt, 3.5 Amp, 50 Hz. Motor thermally protected, single p