FDA UDI
In Commercial Distribution
🇺🇸 United States
Ozeri
DI: 00815817014153
·
Model: TH1-BL
·
COMMONPATH LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ozeri
- Primary DI
- 00815817014153
- Version / Model
- TH1-BL
- Company Name
- COMMONPATH LLC
- Labeler DUNS
- 963223677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-01
- Public Version
- 1
- Public Version Date
- 2021-11-09
- Public Version Status
- New
- Public Device Record Key
- 380db6dc-44bc-4c37-8319-f39f0b741e72
Device Description
The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - Black How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 10815817014150 | GS1 | Giftbox | 1 | In Commercial Distribution | |
| Primary | 00815817014153 | GS1 | ||||
| Package | 20815817014157 | GS1 | Carton box | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- 18772991296
- [email protected]