Duns Number:803593073
Device Description: Transmitters and Receivers, Electrocardiograph, Telephone
Catalog Number
-
Brand Name
Heartrak Smart AF
Version/Model Number
Heartrak Smart AF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
4d088949-cb15-4bdb-9230-f6e8614dd7f7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 21, 2017
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. | 15 |