DEVICE: CVS Health (00050428520062)

Device Identifier (DI) Information

CVS Health
456207
In Commercial Distribution

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
00050428520062
GS1

2
062312574 *Terms of Use
ELECTRODES for Mini TENS device
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GXY Electrode, Cutaneous
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082065 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bc33b354-f1d6-4dd8-8624-c15540b583ae
July 06, 2018
3
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 30050428520063 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-536-0366
info@beurer.com
CLOSE