AccessGUDID - DEVICE: Clinical Health Services, Inc. (00815290016101)

GUDID

Device Identifier (DI) Information

Brand Name: Clinical Health Services, Inc.
Version or Model: CHS230R-WF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CHS230R-WF
Company Name: CLINICAL HEALTH SERVICES, INC.

Primary DI Number: 00815290016101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004416769 *Terms of Use

Device Description: CHS230R-WF- 3" round electrodes, white foam, carbon, plastic zip lock

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160138	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e552809-542f-4d1b-8cdf-1d64e64d53d4
Public Version Date: February 19, 2021
Public Version Number: 3
DI Record Publish Date: March 08, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00815290016125	8	00815290016118	In Commercial Distribution	Master Case
00815290016118	3	10815290016108	In Commercial Distribution	Inner Box
10815290016108	10	00815290016101	In Commercial Distribution	Poly Bag