Duns Number:009251992
Device Description: MULTITECH 3G GATEWAY - ATT KORE
Catalog Number
21996-000105
Brand Name
MULTITECH 3G GATEWAY - ATT KORE
Version/Model Number
21996
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 14, 2016
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
MSX
Product Code Name
SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
Public Device Record Key
9bcd518c-aca6-4b4e-ba7c-87e9f2f03213
Public Version Date
April 06, 2020
Public Version Number
3
DI Record Publish Date
February 01, 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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |
3 | A medical device with high risk that requires premarket approval | 588 |