FDA UDI
In Commercial Distribution
🇺🇸 United States
FeverScan Fever Indicators by Physio Logic
DI: 00057565168102
·
Model: 016-800
·
A.M.G. Médicale Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FeverScan Fever Indicators by Physio Logic
- Primary DI
- 00057565168102
- Version / Model
- 016-800
- Catalog Number
- 016-800
- 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
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- 5d81e8b9-6e5e-459f-9dc3-e86fa35f4b53
Device Description
Fever Scan fever indicators are convenient, fast, and effective in monitoring fever. They indicate temperature in 1 degree Celsius increments for up to 48 hours providing peace of mind day and night. Accurate, fast & safe fever monitoring Continuous monitoring for up to 48 hours even when sleeping Display in Celsius and Fahrenheit Hypoallergenic Each pack contains 6 fever indicators
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | General Hospital | 880.2200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33618 | Liquid-crystal patient thermometer, single-use | A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00057565976042 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00057565168102 | GS1 | ||||
| Package | 00057565976004 | GS1 | Master Case | 48 | In Commercial Distribution |