FDA UDI
In Commercial Distribution
🇺🇸 United States
DrBash
DI: 06972040113498
·
Model: AOJ-20B
·
Shenzhen AOJ Medical Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- DrBash
- Primary DI
- 06972040113498
- Version / Model
- AOJ-20B
- Company Name
- Shenzhen AOJ Medical Technology Co., Ltd
- Labeler DUNS
- 554409093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-29
- Public Version
- 2
- Public Version Date
- 2025-04-28
- Public Version Status
- Update
- Public Device Record Key
- afe7aeed-482c-4248-8eb5-6754e2186337
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 16972040110678 | GS1 | Color box | 1 | In Commercial Distribution | 2029-08-18 |
| Primary | 06972040113498 | GS1 | ||||
| Package | 36972040110122 | GS1 | outer box | 100 | In Commercial Distribution | 2029-08-18 |
| Package | 26972040110606 | GS1 | outer box | 50 | In Commercial Distribution | 2029-08-18 |