EnChroma®
- Primary DI
- 00810750032837
- Brand
- EnChroma®
- Company
- Enchroma Inc.
- Model
- Altavista Matte Black Lx2 Lens
- Device description
- EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma Lx Series lenses and eyewear are intended for use by people with low vision, age-related eye conditions, or other visual impairments to enhance color vision and to reduce glare from bright light. EnChroma eyewear are not suitable for driving and road use. Tinted lenses may impair visibility in low light conditions and should not be used for driving in twilight, night, or through tunnels. Eyewear designed for glare reduction may reduce the discomfort from glare but may not improve visibility in glare conditions. EnChroma Lx Series eyewear are an optical assistive device and are not intended to treat or cure any visual impairment or any other medical condition, such as photosensitive epilepsy. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.
- Published
- 2022-12-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810750032837 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810750032837 | 00810750032837 | 810750032837 | 0810750032837 |
GMDN Terms
| Term | Definition |
|---|
| Colour discrimination non-prescription spectacles | An ophthalmic device consisting of a spectacle frame with a pair of coloured/tinted lenses (non-refractive) designed to be worn in front of the patient’s eyes to enhance colour discrimination in patients with colour vision deficiency; it is not intended to correct refractive vision conditions and is not customized for a specific patient. |
Regulatory Flags
- DUNS number
- 963464198
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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