AccessGUDID - DEVICE: Omron Electrotherapy Pain Relief Long Life Pads (00073796226145)

GUDID

Device Identifier (DI) Information

Brand Name: Omron Electrotherapy Pain Relief Long Life Pads
Version or Model: PMLLPAD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMLLPAD
Company Name: Omron Healthcare, Inc.

Primary DI Number: 00073796226145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054318779 *Terms of Use

Device Description: Electrotherapy Pain Relief Long Life Pads

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Transcutaneous electrical stimulation electrode	A non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

GMDN Preferred Term Name

GMDN Definition

Transcutaneous electrical stimulation electrode

A non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

FDA Product Code

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Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120516	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

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 40 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f572c38b-e7af-438f-9c55-a0128008e9cf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 17, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10073796226142	12	00073796226145	In Commercial Distribution	Inner Carton
20073796226149	4	10073796226142	In Commercial Distribution	Case
50073796226140	8	00073796226145	In Commercial Distribution	boxes of 6 units