FDA UDI
In Commercial Distribution
🇺🇸 United States
YASEE
DI: 06972359497883
·
Model: JA-11A
·
QINGDAO YASEE MEDICAL DEVICE CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YASEE
- Primary DI
- 06972359497883
- Version / Model
- JA-11A
- Company Name
- QINGDAO YASEE MEDICAL DEVICE CO.,LTD
- Labeler DUNS
- 541202125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 1
- Public Version Date
- 2023-12-06
- Public Version Status
- New
- Public Device Record Key
- 5bdfab02-69db-461d-9155-2a0011502e74
Device Description
Infrared Forehead Thermometer is hand-held, battery powered, Infrared Forehead Thermometers that covert a user’s forehead temperature, using the infrared energy emitted in the area around the user’s forehead to an equivalent temperature when measuring from 1-3 cm of the subject’s forehead with no contact.
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
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 06972359497883 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220084 | 000 |