Duns Number:021063219
Device Description: No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
Catalog Number
RNS-6804-7460
Brand Name
NA
Version/Model Number
RNS-6804-7460
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 22, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHX
Product Code Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Public Device Record Key
8cec402c-1543-419f-92b2-031188d6952b
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
January 22, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 393 |