Duns Number:927071162
Device Description: SLW18-3G ECG Cable: Safety Leadwire Three 18''/ 45.7cm Snap Leadwires, Black, Green, and W SLW18-3G ECG Cable: Safety Leadwire Three 18''/ 45.7cm Snap Leadwires, Black, Green, and White.
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
SLW18-3G ECG Cable
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
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
fea6170f-fe7f-4b23-8670-7b299e4aa3b2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
10817325021835
Quantity per Package
100
Contains DI Package
00817325021838
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 |