FDA UDI
In Commercial Distribution
🇺🇸 United States
LIPIVIEW II OCULAR SURFACE INTERFEROMETE
DI: 00859623006612
·
Model: LVI-2000
·
TEARSCIENCE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIPIVIEW II OCULAR SURFACE INTERFEROMETE
- Primary DI
- 00859623006612
- Version / Model
- LVI-2000
- Catalog Number
- 100100
- Company Name
- TEARSCIENCE, INC.
- Labeler DUNS
- 791626901
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2019-10-04
- Public Version Status
- Update
- Public Device Record Key
- 8480b5e2-ece7-4e09-84dd-77df689ff977
Device Description
ASSEMBLY PKGD LIPIVIEW-2 - US
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HKI | Camera, ophthalmic, ac-powered | Ophthalmic | 886.1120 | 2 |
| HJO | Biomicroscope, slit-lamp, ac-powered | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62593 | Meibomian gland camera/ophthalmic interferometer | A mains electricity (AC-powered) multi-purpose optical device intended for: 1) infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands; 2) measurement of the tear film lipid layer using white light image/video capture interferometry; and 3) image capture of the external ocular anatomy. It includes patient head/chin supports, an IR source(s), appropriate cameras, controls and software intended to allow analysis of the images/video and interferometry; it may include an eyelid everter to assist imaging of the meibomian glands. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859623006612 | GS1 |
Customer Contacts
- Phone
- +1(877)266-4543
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 60 Degrees Celsius