Duns Number:100439103
Device Description: AMC - Disp. 6 Lead Grouped Set, Pinch to Molded Nihon Kohden
Catalog Number
-
Brand Name
Advantage Medical Cable ECG Leads
Version/Model Number
RM-LW-381DS50/6A
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
c805e970-e582-47f9-adda-bee6e2668419
Public Version Date
August 02, 2019
Public Version Number
5
DI Record Publish Date
June 30, 2017
Package DI Number
10816317023376
Quantity per Package
25
Contains DI Package
00816317023379
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 68 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |