FDA UDI
In Commercial Distribution
🇺🇸 United States
LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT
DI: 00859623006711
·
Model: CBL-2000
·
TEARSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT
- Primary DI
- 00859623006711
- Version / Model
- CBL-2000
- Catalog Number
- 240100
- 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
- 5
- Public Version Date
- 2019-10-04
- Public Version Status
- Update
- Public Device Record Key
- 81d13917-e6d8-48f7-9dbb-6ca6562cb7e8
Device Description
KIT CABLE PKGD ACTIVATOR II - 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ORZ | Eyelid thermal pulsation system | Ophthalmic | 886.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62688 | Eyelid thermal pulsation system cable/tubing | A non-patient-contact electrical cord and air supply tubing with connectors at each end designed to transmit electrical power and pressurized air between an eyelid thermal pulsation system control unit and its eyelid applicator. It is used for the application of heat and pressure to the outer eyelid surface for the treatment of lid margin disease (LMD), especially meibomian gland dysfunction (MGD). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859623006711 | 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