Duns Number:043081723
Device Description: Advocate Lancing Device Lianfa, adjustable device allowing selection of appropriate depth Advocate Lancing Device Lianfa, adjustable device allowing selection of appropriate depth penetration for maximum comfort in acquiring a capillary blood sample to monitor blood glucose levels
Catalog Number
LD Lianfa
Brand Name
ADVOCATE Lancing Device Lianfa
Version/Model Number
328-B
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
81a57670-9422-4816-9b6d-ffeb8c524769
Public Version Date
November 25, 2020
Public Version Number
2
DI Record Publish Date
June 22, 2020
Package DI Number
10894046001971
Quantity per Package
100
Contains DI Package
00894046001974
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
328-B-C
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |