EnChroma®
- Primary DI
- 00810750033247
- Brand
- EnChroma®
- Company
- Enchroma Inc.
- Model
- Tilden Matte Grey Cx3 Outdoor Sun Lens
- Device description
- EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device only and are not a cure for color blindness. EnChroma lenses are designed for use with deuteranomalous or protanomalous color vision deficiency. The lens is not expected to assist with deuteranopia and protanopia. Effectiveness of the lens may vary depending on the type and extent of color vision deficiency. EnChroma lenses are not designed to defeat color blindness screening tests. 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. When first trying on the lens, the unusual appearance of colors may be visually distracting. Always maintain awareness of potential hazards in your surroundings and take appropriate cautions when engaging in activities such as driving or operation of machinery. The lens is not certified for use in occupations where color blind individuals may be restricted for reasons of public safety, such as emergency first responders, and public transport operators. 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 |
|---|
| 00810750033247 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810750033247 | 00810750033247 | 810750033247 | 0810750033247 |
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
Other Devices From This Company
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|---|
| 16977551440368 | HIT PROMOTIONAL PRODUCTS, INC. | SANMEN HONGYU GLASSES CO., LTD | HQY | 2026-03-06 |
| 16977551440375 | Gold Bond Inc | SANMEN HONGYU GLASSES CO., LTD | HQY | 2026-03-06 |
| 00676190867831 | Superflex Sun Collection | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190867879 | Superflex Sun Collection | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190867916 | Superflex Sun Collection | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190867954 | Superflex Sun Collection | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190867992 | Superflex Sun Collection | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190875461 | One True Pair Sun | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190875508 | One True Pair Sun | WestGroupe Optical Inc | HQY | 2026-03-02 |
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| 00676190875584 | One True Pair Sun | WestGroupe Optical Inc | HQY | 2026-03-02 |
| 00676190875621 | One True Pair Sun | WestGroupe Optical Inc | HQY | 2026-03-02 |
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