FDA UDI
In Commercial Distribution
🇺🇸 United States
Auto Lensmeter
DI: 08800074500251
·
Model: ALM-1P
·
VIEW-M TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Auto Lensmeter
- Primary DI
- 08800074500251
- Version / Model
- ALM-1P
- Catalog Number
- ALM-1P
- Company Name
- VIEW-M TECHNOLOGY CO., LTD.
- Labeler DUNS
- 557821283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-10
- Public Version
- 1
- Public Version Date
- 2023-01-18
- Public Version Status
- New
- Public Device Record Key
- f842d712-01b5-4754-904e-de2f344406dc
Device Description
This device aims to take the measurements of vertex powers, cylinder axis, prismatic power and prism base setting within a restricted area of unprocessed lens, processed framed lens and contact lens, Auto Lensmeter also has functions to measure UV/BLUE transmission. As an external feature, the angle of the LCD can be changed. User is able to measure the PD and OH value with the horizontal and vertical ruler GUI after adjusting the extended LCD at the lowest angle.
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
- 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 | 08800074500251 | GS1 |
Customer Contacts
- Phone
- +827077305148
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius