DEVICE: CVS Health (00050428419960)
Device Identifier (DI) Information
CVS Health
MDTS111
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
MDTS111
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Electronic Pulse Stimulator
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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35372 | Analgesic transcutaneous electrical nerve stimulation system |
An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. 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/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
NGX | Stimulator, Muscle, Powered, For Muscle Conditioning |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 32 and 118 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bdaf8f91-9076-4216-9745-b2e941668932
October 23, 2019
3
August 09, 2016
October 23, 2019
3
August 09, 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 |
---|---|---|---|---|---|
10050428419967 | 24 | 00050428419960 | In Commercial Distribution | shipping case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined