Catalog Number
USB-MEMSTK
Brand Name
RhythmView
Version/Model Number
USB-MEMSTK
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
Yes
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
DQK
Product Code Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Public Device Record Key
f31c57e5-aa26-4597-88e0-f2b26b9c166a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 02, 2016
Package DI Number
30810591020155
Quantity per Package
25
Contains DI Package
00810591020154
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |