FDA UDI
In Commercial Distribution
🇺🇸 United States
LCD Chart monitor
DI: 06971821405012
·
Model: CM-2200
·
Ningbo Ming Sing Optical R & D Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LCD Chart monitor
- Primary DI
- 06971821405012
- Version / Model
- CM-2200
- Company Name
- Ningbo Ming Sing Optical R & D Co., Ltd.
- Labeler DUNS
- 654386890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-30
- Public Version
- 1
- Public Version Date
- 2021-08-09
- Public Version Status
- New
- Public Device Record Key
- e20e2867-a8f9-4c89-b571-7a62ddd3f1c3
Device Description
The space saving chart CM-2200 achieves the refraction distance of 5 m within an installation distance of 0.8 m. The CM-2200 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HOX | Chart, Visual Acuity | Ophthalmic | 886.1150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16800 | Vision testing/training chart | An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971821405012 | GS1 |
Customer Contacts
- Phone
- +86057487305541
- [email protected]