Duns Number:488293218
Device Description: The Medela Disposable Collection System is suitable for the safe collection and disposal o The Medela Disposable Collection System is suitable for the safe collection and disposal of suctioned fluids.
Catalog Number
-
Brand Name
AXS Universal Liner Set
Version/Model Number
077.0194
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
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
c9015a5e-8214-4a79-bb28-fd1208673947
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
June 07, 2018
Package DI Number
07612367054966
Quantity per Package
6
Contains DI Package
07612367054959
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |