Duns Number:004416769
Device Description: CHS230WF- 2"x3.5" electrodes, white foam, carbon, plastic zip lock
Catalog Number
CHS230WF
Brand Name
Clinical Health Services, Inc.
Version/Model Number
CHS230WF
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
a9ea7346-a622-47f5-8ddc-11cdff2f7562
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 11, 2017
Package DI Number
10815290015866
Quantity per Package
10
Contains DI Package
00815290015869
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 |