Duns Number:961027315
Device Description: PUSH BUTTOM ACTIVATED FINGER LANCET
Catalog Number
SLPBHN200
Brand Name
CARDINAL HEALTH
Version/Model Number
SLPBHN200
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"
Yes
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
bf548c22-3a14-4b1f-9e1c-1e70ae497342
Public Version Date
May 13, 2019
Public Version Number
1
DI Record Publish Date
May 03, 2019
Package DI Number
50885380102804
Quantity per Package
18
Contains DI Package
20885380102803
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 |