Duns Number:005036025
Device Description: Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72- Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available.
Catalog Number
1-370-0005
Brand Name
Midmark IQholter® Digital Holter Recorder
Version/Model Number
1-370-0005
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MLO
Product Code Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Public Device Record Key
593aa9d2-3c2a-4168-b0bd-4b5b3d6e882f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |