Duns Number:049735438
Device Description: Mini Lancing Device; Fingertip and Alternative Site Testing; Universal, Fits Most Lancets; Mini Lancing Device; Fingertip and Alternative Site Testing; Universal, Fits Most Lancets; 6 Depth Settings; Compact For Easy Portability; Fingertip and Clear Alternate Site Testing Covers Included
Catalog Number
ZPL12000
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZPL12000
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
7e74e763-f27a-4334-9085-45f23cdf62e8
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
50888499009972
Quantity per Package
400
Contains DI Package
00888499009977
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |