FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LAMEVEN Eye Massager
DI: 06975977230016
·
Model: MD-206
·
Dongguan City Umed Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LAMEVEN Eye Massager
- Primary DI
- 06975977230016
- Version / Model
- MD-206
- Company Name
- Dongguan City Umed Technology Co., Ltd
- Labeler DUNS
- 602090959
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 2
- Public Version Date
- 2023-01-02
- Public Version Status
- Update
- Public Device Record Key
- c370538a-d752-4079-b99a-e90de0466224
- Distribution End Date
- 2023-01-02
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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64742 | Eyelid massager | An electrically-powered ophthalmic device intended to control the application of rotary (oscillating) massage to an eyelid during treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It is a hand-held unit used with disposable tips (not included) intended for eyelid contact; it is intended to be used in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975977230013 | GS1 | 24 | Not in Commercial Distribution | 2023-01-01 | |
| Primary | 06975977230016 | GS1 |