FDA UDI
In Commercial Distribution
🇺🇸 United States
North American Health Wellness
DI: 06926347921614
·
Model: JB8408
·
Shenzhen Brav Electronic Technologies Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- North American Health Wellness
- Primary DI
- 06926347921614
- Version / Model
- JB8408
- Company Name
- Shenzhen Brav Electronic Technologies Co., Ltd.
- Labeler DUNS
- 421279648
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-22
- Public Version
- 1
- Public Version Date
- 2019-08-30
- Public Version Status
- New
- Public Device Record Key
- 483f1795-e338-4dcb-83f9-81b44f869d71
Device Description
EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17887 | Infrared patient thermometer, ear | A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06926347921614 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171214 | 000 |