FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPER
DI: 06970528391109
·
Model: IR-FT
·
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- COMPER
- Primary DI
- 06970528391109
- Version / Model
- IR-FT
- Company Name
- COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
- Labeler DUNS
- 551095493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-12
- Public Version
- 4
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- adb82991-0f1c-45b2-967b-3eb870d1b244
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 | 06970528391109 | GS1 | ||||
| Package | 26970528391103 | GS1 | 52 | In Commercial Distribution | ||
| Package | 16970528391106 | GS1 | 1 | In Commercial Distribution | ||
| Package | 36970528391100 | GS1 | 51 | In Commercial Distribution | ||
| Package | 46970528391107 | GS1 | 50 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191668 | 000 |