Duns Number:783518983
Device Description: • Step-by-step instructions to acquire capillary blood sample.• Adjustable penetration d • Step-by-step instructions to acquire capillary blood sample.• Adjustable penetration depth• Maximum comfort• For use with most lancets
Catalog Number
1171
Brand Name
Easy Mini Eject Lancing Device
Version/Model Number
LF-LDE
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
-
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
0b0e28af-0a81-4be5-846b-1ea94835ab4d
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 03, 2018
Package DI Number
10891237001178
Quantity per Package
100
Contains DI Package
00891237001171
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |