DEVICE: Aleve (00325866564948)
Device Identifier (DI) Information
Aleve
1613579
Not in Commercial Distribution
BAYER HEALTHCARE LLC
1613579
Not in Commercial Distribution
BAYER HEALTHCARE LLC
2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
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 |
---|---|
NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 85 Degrees Fahrenheit |
Handling Environment Temperature: more than -4 Degrees Fahrenheit |
Handling Environment Temperature: less than 149 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
98aaee1b-904b-4407-9b03-0c3b4a1368d7
October 23, 2019
4
September 01, 2016
October 23, 2019
4
September 01, 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 |
---|---|---|---|---|---|
10325866564945 | 6 | 00325866564948 | Not in Commercial Distribution | ||
10325866572445 | 6 | 00325866564948 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
1-800-395-0689
cc-consreldept@bayer.com
cc-consreldept@bayer.com