DEVICE: ProPatch (00185098000443)

Device Identifier (DI) Information

ProPatch
ProM-037
In Commercial Distribution
ProM-037
PRO MEDICAL SUPPLIES, INC.
00185098000443
GS1

1
135741127 *Terms of Use
Electrodes Tan Cloth 1.5"x13.75" (1 electrode per pack)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
Yes
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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132998 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
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 Record Status

64fdca65-2fd9-4f22-beea-7dc81f91b635
July 06, 2018
3
July 26, 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
No Package DIs found
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
215-938-0200
sales@promedspecialties.com
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