DEVICE: 2.25" x 2.50" electrode (00857771003309)

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Device Identifier (DI) Information

2.25" x 2.50" electrode
EDRC225250
EDRC225250
BIOMEDICAL LIFE SYSTEMS INC
00857771003309
GS1
1
20 per pouch
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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No
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
Transcutaneous electrical stimulation electrode A non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
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FDA Product Code

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Product Code Product Code Name
GXY Electrode, Cutaneous
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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
10857771003306 100 00857771003309 In Commercial Distribution inner pack
20857771003303 50 10857771003306 In Commercial Distribution box
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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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Yes
No
No
No
No CLOSE

Customer Contact

[?]
7607275600
information@bmls.com
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