FDA UDI
In Commercial Distribution
🇺🇸 United States
THERMOQUICK; THERMOCLICK; THERMOCARE
DI: 08800065226726
·
Model: MT-3000
·
T&R BIOFAB CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- THERMOQUICK; THERMOCLICK; THERMOCARE
- Primary DI
- 08800065226726
- Version / Model
- MT-3000
- Catalog Number
- MT-3000
- Company Name
- T&R BIOFAB CO.,LTD
- Labeler DUNS
- 689846880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-16
- Public Version
- 1
- Public Version Date
- 2024-01-24
- Public Version Status
- New
- Public Device Record Key
- 2106799e-43d4-4909-8ca1-2dc629d763a7
Device Description
THERMOQUICK is a battery-powered, non-contact infrared thermometer intended to be used to monitor the body temperature of people of all ages. The reference body site of the output temperature is the axilla. A sensor built into the product measures the infrared energy emitted from the skin surface of the forehead within 2cm, so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 08800065228287 | GS1 | Cardboard | 50 | In Commercial Distribution | |
| Primary | 08800065226726 | GS1 | ||||
| Previous | 08800065225781 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222057 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal