FDA UDI
In Commercial Distribution
🇺🇸 United States
CHOSEN Infrared Forehead Thermometer
DI: 00840423500202
·
Model: FTH800
·
ABOUND Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CHOSEN Infrared Forehead Thermometer
- Primary DI
- 00840423500202
- Version / Model
- FTH800
- Catalog Number
- FTH800
- Company Name
- ABOUND Diagnostics, Inc.
- Labeler DUNS
- 119217208
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-11
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- 620428cb-5612-41ed-ba84-eb9faa2f0167
Device Description
CHOSEN Infrared Forehead Thermometer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 63711 | Infrared patient thermometer, ear/skin | A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840423500523 | GS1 | carton | 40 | In Commercial Distribution | |
| Primary | 00840423500202 | GS1 |
Customer Contacts
- Phone
- 8889696928
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190984 | 000 |