Identity
- Trade Name
- Hepa-Care® FDA UDI
- Generic Name
- High-efficiency filter air cleaner, mobile FDA UDI
- Device Name
- Hepa-Care® Portable Unit, 220-240 Volt 3.5 amps 50 Hz ULPA filter. Motor thermally protected single phase. Made in Canada FDA UDI
- Model / Reference
- HC800FTFULPA-G FDA UDI
- Description
- Hepa-Care® Portable Unit, 220-240 Volt 3.5 amps 50 Hz ULPA filter. Motor thermally protected single phase. Made in Canada FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818261020893 FDA UDI
- 510(k) Number
- K984116 FDA UDI
- FDA Product Code
- FRF FDA UDI
- GMDN Term
- High-efficiency filter air cleaner, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: High-efficiency filter air cleaner, mobile
Hepa-Care® by Abatement Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984116 also covers:
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- HEPA-CARE® — Abatement Technologies, Inc.
- Hepa-Care® — Abatement Technologies, Inc.
- Hepa-Care® — Abatement Technologies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abatement Technologies, Inc.
Sources (1)
- FDA UDI ccb6ca92-05a3-47ad-9505-0749722a3687 35 fields · synced May 31, 2026