Duns Number:306032491
Device Description: Single use infusion set for subcutaneous infusion. The infusion set must be used as descri Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Catalog Number
-
Brand Name
Autosoft XC
Version/Model Number
1003912
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
a7fc334c-aae3-4adf-a6f9-5ad0ff3e0f47
Public Version Date
March 25, 2019
Public Version Number
1
DI Record Publish Date
March 15, 2019
Package DI Number
05705244021105
Quantity per Package
100
Contains DI Package
05705244021099
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |