DEVICE: CVS Health (00050428520062)
Device Identifier (DI) Information
CVS Health
456207
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
456207
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
ELECTRODES for Mini TENS device
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 27 Degrees Celsius |
Storage Environment Humidity: between 35 and 50 Percent (%) Relative Humidity |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Handling Environment Humidity: between 40 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bc33b354-f1d6-4dd8-8624-c15540b583ae
February 19, 2021
5
September 24, 2016
February 19, 2021
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20050428520066 | 4 | 10050428520069 | In Commercial Distribution | Case Pack | |
10050428520069 | 6 | 00050428520062 | In Commercial Distribution | Inner Pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
30050428520063
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-536-0366
info@beurer.com
info@beurer.com