DEVICE: Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads (00855944007659)

Device Identifier (DI) Information

Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads
ETP015
In Commercial Distribution

EASY HEALTHCARE CORPORATION
00855944007659
GS1

2
080278407 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
59689 Neuromuscular transmission electrode
A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141260 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

d97d5f3f-49c4-4e6b-9db9-75dc2ae4a27c
August 08, 2019
1
July 31, 2019
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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
10855944007656 30 00855944007659 In Commercial Distribution 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: 90855944007652 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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