Duns Number:196880520
Device Description: ASSY, COLOR LED DOT MATRIX DISPLAY with EZ95 Firmware
Catalog Number
0707-1151
Brand Name
Arial
Version/Model Number
0707-1151
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
IQA
Product Code Name
System, Environmental Control, Powered
Public Device Record Key
b340900f-794b-42f6-b29e-bda199d617f5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 51 |
2 | A medical device with a moderate to high risk that requires special controls. | 94 |