color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len
- Primary DI
- 06975326564298
- Brand
- color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len
- Company
- Shenzhen Dashicheng Optical Technology Co., Ltd.
- Model
- BARBIE
- Device description
- BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.Frequent/Planned Replacement Wear:Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.Disposable Wear:Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
- Published
- 2024-03-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K220143 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06975326564298 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06975326564298 | 06975326564298 | 6975326564298 |
GMDN Terms#
| Term | Definition |
|---|---|
| Soft corrective contact lens, daily-disposable | A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 543028405
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06931219451656 | color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-12-10 | |
| 86931219451652 | color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-12-10 | |
| 06931219454961 | color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-11-17 | |
| 86931219454967 | color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-11-17 | |
| 06931219444658 | Huneyes; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-09-17 | |
| 86931219444654 | Huneyes; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-09-17 | |
| 06931219402290 | Unicoeye;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2025-03-18 | |
| 06975326561525 | Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2024-10-14 | |
| 06975326564304 | color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len | BARBIE | 2024-03-11 | |
| 06975326561501 | Moody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-06-19 | |
| 06975326560979 | Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 | |
| 06975326561051 | Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 | |
| 06975326561259 | Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 | |
| 06975326567763 | Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 | |
| 06975326567770 | Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 | |
| 06975326567787 | Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | BARBIE | 2023-05-22 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06942686575905 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575905 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575912 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575912 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575929 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575929 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575936 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575936 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575943 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575943 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575950 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575950 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575967 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575967 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575974 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575974 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575981 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575981 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686575998 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686575998 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686576001 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686576001 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686576018 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686576018 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686576025 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686576025 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686576032 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686576032 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |
| 06942686576049 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | MVN | 2026-07-17 |
| 06942686576049 | coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | LPL | 2026-07-17 |