FDA UDI
In Commercial Distribution
🇺🇸 United States
COCET
DI: 06943532402802
·
Model: KFT-28
·
Kangfu Medical Equipment Factory
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COCET
- Primary DI
- 06943532402802
- Version / Model
- KFT-28
- Company Name
- Kangfu Medical Equipment Factory
- Labeler DUNS
- 528773018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-18
- Public Version
- 1
- Public Version Date
- 2022-04-26
- Public Version Status
- New
- Public Device Record Key
- fcc90e0a-2290-4720-81c3-c83b8efe0584
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
- MR Safe
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
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 | 06943532402802 | GS1 |