Duns Number:480868538
Device Description: The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Catalog Number
0.282200
Brand Name
medilog DARWIN2 U
Version/Model Number
0.282200
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
K053369
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
4bff849e-fe07-4460-b9f2-a634108f4e74
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 23, 2021
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |