Duns Number:088302096
Catalog Number
33968-3AUS
Brand Name
Accutron E-Z Q/C Hose Set 3', Australian
Version/Model Number
33968-3AUS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 12, 2099
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
3976e837-011a-4522-92a7-9d6d41569810
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |