Duns Number:079403749
Device Description: EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, EKG Glove, a disposable latex glove containing electrodes which when applied to the skin, collect data for an EKG - Medium size
Catalog Number
-
Brand Name
EKG Glove
Version/Model Number
Medium Size
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
K033559,K100315
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
38c9d8ac-9566-4eca-8b72-083c1ffd45d6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |