DEVICE: PURE ENRICHMENT (B311PEPROPAD0)

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Device Record History
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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© 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?
35995 Transcutaneous electrical stimulation electrode, single-use
An 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 (EMS), 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-use device.
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
61b8460a-2b49-4a32-9185-3c57cc4d8a2e
June 28, 2022
6
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
B311PEPROPAD6 250 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

[?]
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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