Duns Number:803035633
Device Description: Stress Echo Bed
Catalog Number
-
Brand Name
Stress Echo Bed
Version/Model Number
1736
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
LGX
Product Code Name
Table, Examination, Medical, Powered
Public Device Record Key
6293873f-046f-4208-9803-c135eb239b00
Public Version Date
August 27, 2020
Public Version Number
1
DI Record Publish Date
August 19, 2020
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 | 53 |