Duns Number:025460908
Device Description: ELECTRODE,ECG,TAB,10/CARD,5000/CS, ADULT
Catalog Number
MDSM616201
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDSM616201
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
-
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
9ff27956-1a3a-449d-86b6-3c8a2c2e2572
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
December 25, 2020
Package DI Number
30888277352333
Quantity per Package
500
Contains DI Package
80888277352338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |