Catalog Number
-
Brand Name
AutoFuser
Version/Model Number
MC0050L
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
9ed78e50-484e-4555-a943-0dd6da9353d7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2016
Package DI Number
88806139603635
Quantity per Package
100
Contains DI Package
08806139603639
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-