FDA UDI
In Commercial Distribution
🇺🇸 United States
FDK
DI: 00859020006048
·
Model: FT-F11
·
Fudakang Industrial Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- FDK
- Primary DI
- 00859020006048
- Version / Model
- FT-F11
- Company Name
- Fudakang Industrial Inc.
- Labeler DUNS
- 118811334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-21
- Public Version
- 9
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- f37ac455-1989-46f9-b323-1f0348b15715
Device Description
FDK EAR TYPE INFRARED THERMOMETER
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
- 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 |
|---|---|---|---|---|
| 17887 | Infrared patient thermometer, ear | A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859020006048 | GS1 | ||||
| Package | 10859020006045 | GS1 | Case | 96 | In Commercial Distribution | |
| Package | 20859020006042 | GS1 | Inner Pack | 16 | In Commercial Distribution | |
| Package | 30859020006049 | GS1 | Case | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111703 | 000 |