Duns Number:071595540
Device Description: IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
Catalog Number
590458
Brand Name
IVY BIOMEDICAL
Version/Model Number
590458
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K991105,K991105,K991105
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
975126e8-402c-48fe-86e2-0f4034af25f6
Public Version Date
July 19, 2021
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
20653405082559
Quantity per Package
100
Contains DI Package
10653405082552
Package Discontinue Date
July 17, 2021
Package Status
Not 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |