Duns Number:962750381
Device Description: TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger A TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter
Catalog Number
5-100
Brand Name
TearCare(TM) (2.2) System Kit
Version/Model Number
FG 06041
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
65e9fe0a-f327-4e88-b0d9-6a43fd74c8b0
Public Version Date
July 25, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |