Duns Number:688006266
Device Description: DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients.
Catalog Number
-
Brand Name
DANA 3cc Syringe
Version/Model Number
DANA 3cc Syringe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071418,K071418,K071418
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
b84b5142-c168-4cf7-99c3-17e2402f5bdb
Public Version Date
August 23, 2018
Public Version Number
4
DI Record Publish Date
August 12, 2016
Package DI Number
08809220580772
Quantity per Package
10
Contains DI Package
08809220580765
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |