Duns Number:422528088
Device Description: he Droplet Lncing Device is a convenient medical device for use with exchangeable lancets he Droplet Lncing Device is a convenient medical device for use with exchangeable lancets in order to collect capillary blood samples for glucose monitoring or other tests.
Catalog Number
9006
Brand Name
Droplet, Lancing Device
Version/Model Number
n/a
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
7ea9d88d-7913-454f-8c80-38e980f38ad3
Public Version Date
November 11, 2019
Public Version Number
1
DI Record Publish Date
November 01, 2019
Package DI Number
15907996090324
Quantity per Package
40
Contains DI Package
05907996090327
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |