Duns Number:043081723
Device Description: Advocate Lancing Device Red Dot, ergonomically designed, safety switch feature locks the t Advocate Lancing Device Red Dot, ergonomically designed, safety switch feature locks the trigger when uncapped, 6 depth adjustment, safer, easier lancet ejection
Catalog Number
329
Brand Name
ADVOCATE Lancing Device Red Dot
Version/Model Number
329
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
3a14fbd7-fc98-4ee6-88a0-2adac2899359
Public Version Date
July 21, 2020
Public Version Number
2
DI Record Publish Date
June 22, 2020
Package DI Number
10852982006009
Quantity per Package
100
Contains DI Package
00852982006002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |