ProScan Non-Contact Infrared Thermometer by Physio Logic
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Basic Information
- Brand Name
- ProScan Non-Contact Infrared Thermometer by Physio Logic
- Primary DI
- 00057565166603
- Version / Model
- 016-660
- 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
- 2020-03-04
- Public Version
- 5
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 47f890f7-845e-42b7-ad6f-7808fd64566c
Device Description
3 in 1 Thermometer: Body, Room, Liquids and surfaces Non-contact infrared probe Professional Accuracy Faster and more precise than an ear thermometer Non-Contact up to 1- 2" (3 cm - 5 cm) distance from forehead. This means a greatly reduced risk of contagion, without the need for probe covers. Back-lit screen with colour-coded fever alert: green for normal, orange for a low fever and red for a fever of or above 38 C (100.4 F). Fully programmable alerts can be set to detect fever for a specific age group or illness. Use it to ensure that food temperature is safe before serving. Prevent scalding due to hot bath water. Audio alert signals peak temperature and fever. Voice feature can assist users with impaired vision and can be set to English, French, Spanish or mute. Keeps the last 32 temperature readings in memory. Displays in C or F. Auto shut-off for extended battery life. Longevity: 40,000 readings. 2 alkaline AA batteries included.
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
- 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 | 00057565166603 | GS1 | ||||
| Package | 00057565942641 | GS1 | Retail | 1 | Not in Commercial Distribution | 2020-03-11 |
| Package | 00057565999126 | GS1 | Case | 6 | Not in Commercial Distribution | 2020-03-11 |
| Package | 05756594264148 | GS1 | Retail box | 1 | In Commercial Distribution | |
| Package | 05756599912648 | GS1 | Master case | 6 | In Commercial Distribution | |
| Package | 10057565942648 | GS1 | Retail Box | 1 | In Commercial Distribution | |
| Package | 20057565999120 | GS1 | Master Case | 6 | In Commercial Distribution | |
| Package | 10057565166600 | GS1 | Master case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-363-2381
- [email protected]