Duns Number:688006266
Device Description: Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insul Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
Catalog Number
-
Brand Name
Soft-Release-ST
Version/Model Number
SR112
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
K022317,K022317,K022317
Product Code
LZG
Product Code Name
Pump, Infusion, Insulin
Public Device Record Key
3df84461-7a80-42a5-8503-094a9442ee44
Public Version Date
September 12, 2018
Public Version Number
5
DI Record Publish Date
August 12, 2016
Package DI Number
08809220580758
Quantity per Package
10
Contains DI Package
08809220580413
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 |