FDA UDI
In Commercial Distribution
🇺🇸 United States
Hepa-Care®
DI: 00818261021005
·
Model: UV800F
·
ABATEMENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hepa-Care®
- Primary DI
- 00818261021005
- Version / Model
- UV800F
- Company Name
- ABATEMENT TECHNOLOGIES, INC.
- Labeler DUNS
- 173503806
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-11
- Public Version
- 8
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 28ba1cb2-e876-4f30-9977-81828974e56b
Device Description
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRF | Cleaner, Air, Medical Recirculating | General Hospital | 880.5045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35150 | Ultraviolet ambient disinfection light | An electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818261021005 | GS1 |
Customer Contacts
- Phone
- 18006349091
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K984116 | 000 |