Duns Number:147035427
Device Description: M12R L Recorder, 10-Lead Cable, AHA, System Kit90815187020184; M12R, 10 Lead patient Cable M12R L Recorder, 10-Lead Cable, AHA, System Kit90815187020184; M12R, 10 Lead patient Cable (DIN)90815187020252; M12R Holter Recorder90815187020320; M12R Carrying Case
Catalog Number
001-400-0123
Brand Name
Matrix Holter System
Version/Model Number
001-400-0123
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)
Yes
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
K051730
Product Code
MLO
Product Code Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Public Device Record Key
f5c910ca-63ba-4a83-bdb3-7f2e0047ff8f
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 29, 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. | 49 |