Duns Number:354023236
Device Description: WASHER DISINFECTOR 46-5 S+NO D, S+NO D indicating single door machine without dryer.Cat no WASHER DISINFECTOR 46-5 S+NO D, S+NO D indicating single door machine without dryer.Cat no was 46-5-400. From March 2019 new cat no is 46-5-500.
Catalog Number
46-5-500
Brand Name
GETINGE 46-SERIES
Version/Model Number
46-5
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
-
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
MEC
Product Code Name
Disinfector, Medical Devices
Public Device Record Key
2ad71fba-869e-41e6-86c2-5a5e16e68635
Public Version Date
April 12, 2019
Public Version Number
3
DI Record Publish Date
September 22, 2016
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |