Catalog Number
-
Brand Name
AutoFuser
Version/Model Number
MC0080XL
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"
Yes
For Single-Use
Yes
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
MEB
Product Code Name
Pump, Infusion, Elastomeric
Public Device Record Key
be325c35-3fb4-454e-9ca5-ac103914e30f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2016
Package DI Number
58806139603900
Quantity per Package
50
Contains DI Package
08806139603905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-