AccessGUDID - DEVICE: Bio Protech (00817120021385)

GUDID

Device Identifier (DI) Information

Brand Name: Bio Protech
Version or Model: HiDow Palm Shape Tens Electrodes (2x3in BP Gel)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIO PROTECH USA, INC.

Primary DI Number: 00817120021385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789127011 *Terms of Use

Device Description: HiDow Palm Shape Tens Electrodes (2x3in BP Gel) - 2 pcs per pack/pouch, Multi use self-adhesive electrodes, Tens Electrodes with BP Gel

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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: 0d8ae4b3-7aaa-468d-8b3d-4eb82de56cdd
Public Version Date: February 19, 2021
Public Version Number: 3
DI Record Publish Date: January 17, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30817120021386	5	20817120021389	In Commercial Distribution	Master Case
20817120021389	10	10817120021382	In Commercial Distribution	Inner Box
10817120021382	10	00817120021385	In Commercial Distribution	Poly Bag