DEVICE: CVS Health (00050428419960)

Device Identifier (DI) Information

CVS Health
MDTS111
In Commercial Distribution

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
00050428419960
GS1

1
062312574 *Terms of Use
Electronic Pulse Stimulator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
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
Analgesic TENS system An assembly of battery-powered devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of external current generator and electrodes that are placed on the skin to provide the transcutaneous analgesic electrical stimulus to the painful area. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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FDA Product Code

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Product Code Product Code Name
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 32 and 118 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bdaf8f91-9076-4216-9745-b2e941668932
March 29, 2018
2
August 09, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10050428419967 24 00050428419960 In Commercial Distribution shipping case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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