FDA UDI
In Commercial Distribution
🇺🇸 United States
LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE
DI: 00859623006315
·
Model: LFD-2000
·
TEARSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE
- Primary DI
- 00859623006315
- Version / Model
- LFD-2000
- Catalog Number
- 221050
- Company Name
- TEARSCIENCE, INC.
- Labeler DUNS
- 791626901
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-24
- Public Version
- 8
- Public Version Date
- 2025-01-20
- Public Version Status
- Update
- Public Device Record Key
- 09a06cf3-bc19-42bb-9c4f-7e790857caa3
Device Description
ACTIVATORS (BOX OF 10) US
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORZ | Eyelid thermal pulsation system | Ophthalmic | 886.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58218 | Eyelid thermal pulsation system applicator, single-use | An ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859623006333 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00859623006315 | GS1 |
Customer Contacts
- Phone
- +1(877)266-4543
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 6 | Pound per Square Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius