Duns Number:078431936
Device Description: The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a ce The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations.
Catalog Number
-
Brand Name
Tasso-M20
Version/Model Number
K1001-02
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
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
95985f1e-7b2b-4060-ad10-9e446d8847f7
Public Version Date
July 28, 2021
Public Version Number
1
DI Record Publish Date
July 20, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |