Hepa-Care®
GUDID 00818261020909
Hepa-Care® Ceiling Unit, 115 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Mechanical safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada
ABATEMENT TECHNOLOGIES, INC.
High-efficiency filter air cleaner, stationary| Primary Device ID | 00818261020909 |
| NIH Device Record Key | 6fde59b4-2d59-421b-b55e-402e058b3e79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hepa-Care® |
| Version Model Number | HC800C |
| 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 |
| iaqinfo@abatement.com | |
| Phone | 18006349091 |
| iaqinfo@abatement.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818261020909 [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 |
Trademark Results [Hepa-Care]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEPA-CARE 74538091 1991770 Live/Registered |
Abatement Technologies, Inc. 1994-06-15 |
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