DEVICE: Well at Walgreens (00311917176406)

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Device Record History
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Device Identifier (DI) Information
Well at Walgreens
FDES105B Body Pads (P105B-2)
In Commercial Distribution

WALGREEN CO.
00311917176406
GS1

3
008965063 *Terms of Use
2.08" X 2.87" gel electrodes body pads
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GXY Electrode, Cutaneous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K130723 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Area/Surface Area: 5.97 Square inch
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Device Record Status
56f7184a-d8e2-473c-8771-6d7b30a0851e
October 23, 2019
4
August 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10311917176403 120 00311917176406 2016-10-19 Not in Commercial Distribution 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

[?]
Unit of Use DI Number: 20311917176400 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-877-365-6274
consumerrelations.pq@walgreens.com
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