Duns Number:196880520
Device Description: SERVER CONFIGURED, WIN 10, 64 BIT - Wi-Fi E-CALL
Catalog Number
-
Brand Name
Arial
Version/Model Number
0900-989
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
4f7aeb6d-f758-49be-82b7-905439c35f86
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 30, 2017
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 |