Duns Number:961027315
Device Description: Push Button Activated Finger Lancet
Catalog Number
SLPB25200
Brand Name
CARDINAL HEALTH
Version/Model Number
SLPB25200
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
35fb7657-ff48-4959-b3c5-1bca7baa56c4
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 2021
Package DI Number
50885380171015
Quantity per Package
20
Contains DI Package
20885380171014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |