FDA UDI
In Commercial Distribution
🇺🇸 United States
Physiologic Insta-Therm Quick-Scan Thermometer
DI: 00057565166702
·
Model: 016-670
·
A.M.G. Médicale Inc
Product Codes
1
GMDN Terms
2
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- Physiologic Insta-Therm Quick-Scan Thermometer
- Primary DI
- 00057565166702
- Version / Model
- 016-670
- Company Name
- A.M.G. Médicale Inc
- Labeler DUNS
- 207372814
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 5
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- e9fc993d-598e-412f-ab7c-a12c055730e4
Device Description
This thermometer's innovative design offers 2 convenient and accurate ways to measure body temperature instantly.The Insta-Therm Quick-Scan’s innovative infrared technology allows probe-free scanning from either the ear or forehead. Requires no probe covers! Innovative design allows for choice of 2 body temperature measuring options: Ear and Forehead. Memory stores last 10 readings.
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
| 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 | 05756598834224 | GS1 | 10 | In Commercial Distribution | ||
| Package | 05756598833548 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00057565166702 | GS1 | ||||
| Package | 10057565166709 | GS1 | Inner box | 6 | In Commercial Distribution | |
| Package | 20057565166706 | GS1 | Master case | 10 | In Commercial Distribution | |
| Previous | 05756516670200 | GS1 |