DEVICE: Well at Walgreens (00311917176390)

Device Identifier (DI) Information

Well at Walgreens
FDES150B Back Pads (P105B-1)
In Commercial Distribution

WALGREEN CO.
00311917176390
GS1

2
008965063 *Terms of Use
7.48" x 3.74" gel electrodes back pads.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
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
GXY Electrode, Cutaneous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130723 000
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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 50 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Area/Surface Area: 27.98 Square inch
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Device Record Status

2f339e28-1b01-4eb9-acc3-efd139b065e7
July 06, 2018
3
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
10311917176397 60 00311917176390 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

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Unit of Use DI Number: 20311917176394 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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