Duns Number:927071162
Device Description: MXC32R-5 ECG: Cloth, Universal Round 32mm ECG Electrode, 5pcs/Pack, 100pcs/Box, 1000pcs/M MXC32R-5 ECG: Cloth, Universal Round 32mm ECG Electrode, 5pcs/Pack, 100pcs/Box, 1000pcs/Master Case
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
MXC32R-5 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
K020003,K020003,K020003
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
25973dfa-2ca8-4dc8-9285-eb5e2bd64d6a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
20817325022280
Quantity per Package
10
Contains DI Package
10817325022283
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 |