Duns Number:927071162
Device Description: MXF55RW-3 ECG: PE Foam, Wet Gel, Adult Round 55mm ECG Electrode, 3pcs/Pack, 60pcs/Box, 600 MXF55RW-3 ECG: PE Foam, Wet Gel, Adult Round 55mm ECG Electrode, 3pcs/Pack, 60pcs/Box, 600pcs/Master Case
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
MXF55RW-3 ECG
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"
Yes
For Single-Use
Yes
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
K083148,K083148,K083148
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
7d3dd232-8d7a-43ce-8ab7-6970837347d2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2016
Package DI Number
20817325022334
Quantity per Package
10
Contains DI Package
10817325022337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| 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. | 309 |