FDA UDI
In Commercial Distribution
🇺🇸 United States
Another Me Kristin Monthly
DI: 08800071415473
·
Model: Another Me Kristin Monthly
·
DK MEDIVISION Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Another Me Kristin Monthly
- Primary DI
- 08800071415473
- Version / Model
- Another Me Kristin Monthly
- Company Name
- DK MEDIVISION Co.,Ltd.
- Labeler DUNS
- 688303758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-02-11
- Public Version
- 1
- Public Version Date
- 2026-02-19
- Public Version Status
- New
- Public Device Record Key
- 9426bdac-7e57-4df2-be16-02357e0ac0ba
Device Description
Another Me Kristin Monthly/Gray Color/-1.50/2EA
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48742 | Barmah Forest (BF) virus nucleic acid IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Barmah Forest (BF) virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08800071419341 | GS1 | ||||
| Primary | 08800071415473 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220045 | 000 |