FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTO LENSMETER
DI: 04987669100622
·
Model: LM-1800P
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AUTO LENSMETER
- Primary DI
- 04987669100622
- Version / Model
- LM-1800P
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-20
- Public Version
- 1
- Public Version Date
- 2018-05-21
- Public Version Status
- New
- Public Device Record Key
- 2b7b3e3d-c679-418e-bb6f-e59040f0940a
Device Description
The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side.
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 |
|---|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | Ophthalmic | 886.1425 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12326 | Manually-adjusted lensmeter, line-powered | A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987669100622 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]