VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer
Basic Information
- Brand Name
- VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer
- Primary DI
- 00853483008250
- Version / Model
- HA-650
- Catalog Number
- HA-650
- Company Name
- Able Diagnostics Inc
- Labeler DUNS
- 080952036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-08
- Public Version
- 1
- Public Version Date
- 2020-12-16
- Public Version Status
- New
- Public Device Record Key
- dbbd7278-d27f-4aa7-a2fb-b2bb7b1f1a47
Device Description
Accurate and Quick: (1) Advanced infrared technology with a unique Chromed Arched Reflector provides highly accurate and quick measurements in 1 second; (2) Features wide body temperature measuring range between 93.2°F – 109.4°F; (3) Offers reliable results in a wide environmental temperature range at 50.0°F – 104.0°F; No Touch and Safer Measurements: (1) Hold the Non-contact thermometer 0.4 – 2 inches away from the center of forehead to obtain measurement; (2) No measuring sensor cover is needed; (3) Minimizes the risk of spread of disease and cross-contamination; (4) Eliminates the need for cleaning between each person; Easy to Use: (1) Easy to read digital LCD display includes 3 backlight colors and features Red High Fever Alert above 101.3°F; (2) User-friendly design offers comfortable grip; (3) Storage for up to 50 measurement memories; (4) Switchable between °F/°C and beep/silent options; (5) 2 AAA batteries included.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853483008250 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190984 | 000 |