Duns Number:306032491
Device Description: Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as described in the Instruction for Use.
Catalog Number
-
Brand Name
MiniMed™ Duo™ Infusion Tubing
Version/Model Number
5082076-001
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
K002138,K002138,K002138
Product Code
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
b8feca27-6a29-4162-9f10-5c634b74c78d
Public Version Date
September 13, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
05705244005228
Quantity per Package
200
Contains DI Package
05705244005211
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 |