FDA UDI
In Commercial Distribution
🇺🇸 United States
YEASN
DI: 06971922134026
·
Model: HX-400
·
Chongqing Yeasn Science & Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YEASN
- Primary DI
- 06971922134026
- Version / Model
- HX-400
- Catalog Number
- HX4/1
- Company Name
- Chongqing Yeasn Science & Technology Co.,Ltd.
- Labeler DUNS
- 547954649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-21
- Public Version
- 1
- Public Version Date
- 2022-03-29
- Public Version Status
- New
- Public Device Record Key
- ca965377-a26d-4072-bc27-881e9d1bcb77
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HLH | Pupillometer, Manual | Ophthalmic | 886.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32727 | Pupillometer, manual | A manually-operated ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. Evaluation of the pupil is done by manually assessing the size of the pupil to parameters on this device, e.g., holes or scaled measurements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971922134026 | GS1 |