Duns Number:481742760
Device Description: Soft-Release-O Infusion Set, 9 mm soft cannula, 30 cm (12") blue tubing. / Infusion set wi Soft-Release-O Infusion Set, 9 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a soft cannula designed to work with the DANA DIABECARE insulin pump.
Catalog Number
S3091
Brand Name
Soft-Release-O
Version/Model Number
S3091
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
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
ed190843-5f34-4833-8d5a-3ea286cd4933
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
07613117010416
Quantity per Package
10
Contains DI Package
07613117010409
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIPPER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |