Duns Number:688006266
Device Description: DANA Easy Setter is an accessory for insulin pump use. it helps the length of linking scre DANA Easy Setter is an accessory for insulin pump use. it helps the length of linking screw adjusted properly.If the length adjustment of linking screw is fail, the insulin could not be delivered.
Catalog Number
-
Brand Name
DANA Easy Setter
Version/Model Number
DANA Easy Setter
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063126
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
6f684e95-3530-472a-a5d9-ce90a422acb2
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |