Duns Number:600039072
Device Description: The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancing device cover prevents the user from unintentional punctures.
Catalog Number
-
Brand Name
Dario 100 Sterile Lancets
Version/Model Number
1121-05
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)
-
Over the Counter (OTC)
Yes
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
ad881d90-bd33-48a1-a801-d6ed6d72a672
Public Version Date
August 18, 2021
Public Version Number
1
DI Record Publish Date
August 10, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |