Duns Number:004416769
Device Description: CHS220WF- 2"x2" electrodes, white foam, carbon, plastic zip lock
Catalog Number
CHS220WF
Brand Name
Clinical Health Services, Inc.
Version/Model Number
CHS220WF
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160138,K160138,K160138,K160138
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
748f2871-c9c7-46d2-a374-4626457e3da2
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
April 11, 2017
Package DI Number
10815290015521
Quantity per Package
10
Contains DI Package
00815290015524
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
poly bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |