Duns Number:431082693
Device Description: Helion Unit for manage bidirectional A/V videoconferencing. Main Features: - Dual channel Helion Unit for manage bidirectional A/V videoconferencing. Main Features: - Dual channel transmission support; - Control directly via Helion GUI and Touchscreen; - Connections with remote users or any third-party videoconferencing unit supporting H.323 and SIP communication protocols; - Video Input/Output: FullHD bidirectional full duplex (2 separate video channels); - Audio: bidirectional full-duplex; - Protocols:H.323 and SIP.
Catalog Number
CM401326
Brand Name
HELION
Version/Model Number
116001
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
279242d5-658b-4bae-98cb-5cb814ed7615
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |