Duns Number:927071162
Device Description: MXC55R-3 ECG: Cloth, Round 55mm, Solid Gel, ECG Electrode, 3pcs/Pack, 60pcs/Box, 600pcs/Ma MXC55R-3 ECG: Cloth, Round 55mm, Solid Gel, ECG Electrode, 3pcs/Pack, 60pcs/Box, 600pcs/Master Case
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
MXC55R-3 ECG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
K020003,K020003,K020003
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
318c4b7b-d5db-4860-aa24-6ae09f001f79
Public Version Date
December 31, 2018
Public Version Number
5
DI Record Publish Date
February 01, 2017
Package DI Number
10817325022733
Quantity per Package
20
Contains DI Package
00817325022736
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Inner Box
| 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 |