Duns Number:078431936
Device Description: The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillar The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Catalog Number
-
Brand Name
Tasso+
Version/Model Number
K1013-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
K221131,K221131
Product Code
FMK
Product Code Name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Public Device Record Key
06072da4-7fba-4fa2-b89c-ec3d8e4f58f9
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
10850038691001
Quantity per Package
60
Contains DI Package
00850038691004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |