| Primary Device ID | 00859623006414 |
| NIH Device Record Key | e7d681fd-96d8-45fd-b5fb-235fb99f7fec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIPIFLOW SYSTEM CONSOLE |
| Version Model Number | LFTP-1000 |
| Catalog Number | 210000 |
| Company DUNS | 791626901 |
| Company Name | TEARSCIENCE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Pressure | 6 Pound per Square Inch |
| Handling Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859623006414 [Primary] |
| ORZ | Eyelid thermal pulsation system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-04 |
| Device Publish Date | 2016-09-23 |
| 00859623006001 - MEIBOMIAN GLAND EVALUATOR | 2020-03-05 MEIBOMIAN GLAND EVALUATOR - GBL |
| 00859623006018 - MEIBOMIAN GLAND EVALUATOR | 2020-03-05 MEIBOMIAN GLAND EVALUATOR - AU,CA,US |
| 20859623006135 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) | 2020-03-05 ACTIVATORS (BOX OF 10) US |
| 00859623006216 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) | 2020-03-05 ACTIVATORS (BOX OF 10) US |
| 20859623006333 - LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE | 2020-03-05 ACTIVATORS (BOX OF 10) US |
| 00859623006414 - LIPIFLOW SYSTEM CONSOLE | 2019-10-04ASSEMBLY PKGD LIPIFLOW - US |
| 00859623006414 - LIPIFLOW SYSTEM CONSOLE | 2019-10-04 ASSEMBLY PKGD LIPIFLOW - US |
| 00859623006513 - LIPIVIEW OCULAR SURFACE INTERFEROMETER | 2019-10-04 ASSEMBLY PKGD LIPIVIEW 1 - INTL |
| 00859623006612 - LIPIVIEW II OCULAR SURFACE INTERFEROMETE | 2019-10-04 ASSEMBLY PKGD LIPIVIEW-2 - US |