FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040193228
·
Model: 5705564
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040193228
- Version / Model
- 5705564
- Catalog Number
- 5705564
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- b77bc33c-2690-4ec7-be5d-e2fd6b18bbcc
Device Description
Vital Signs Monitor Infrared Forehead Thermometer
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 | Continuous Measurement Thermometer | 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 | 00304040193228 | GS1 |