Duns Number:020198912
Device Description: 5-Lead Set, Disposable, Chest, AAMI
Catalog Number
989803192141
Brand Name
N/A
Version/Model Number
N/A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
b98c75b6-2481-44c2-a7c4-a593a76cdd3f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 14, 2017
Package DI Number
57613327361914
Quantity per Package
20
Contains DI Package
07613327361919
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 | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |