DEVICE: PURE ENRICHMENT (B311PEPROPAD0)

Device Identifier (DI) Information

PURE ENRICHMENT
PEPROPAD
In Commercial Distribution

BEAR DOWN CONSULTING
B311PEPROPAD0
HIBCC

1
040869867 *Terms of Use
PACK OF ELECTRODES
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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
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

[?]
Product Code Product Code Name
GXY Electrode, Cutaneous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082065 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

61b8460a-2b49-4a32-9185-3c57cc4d8a2e
July 06, 2018
3
October 19, 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
B311PEPROPAD4 50 B311PEPROPAD0 In Commercial Distribution MASTER CARTON
B311PEPROPAD3 10 B311PEPROPAD0 In Commercial Distribution INDIVIDUAL PACKAGE
B311PEPROPAD2 100 B311PEPROPAD0 In Commercial Distribution MASTER CARTON
B311PEPROPAD1 5 B311PEPROPAD0 In Commercial Distribution INDIVIDUAL PACKAGE
B311PEPROPAD5 400 B311PEPROPAD0 In Commercial Distribution MASTER CARTON
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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

[?]
714-668-0300
SUPPORT@PUREENRICHMENT.COM
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