DEVICE: BioMed Revived (00857771003965)

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Device Identifier (DI) Information

BioMed Revived
Revived
BRVE
BIOMEDICAL LIFE SYSTEMS INC
00857771003965
GS1
1
No description.
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Device Characteristics

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

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Analgesic TENS system An assembly of battery-powered devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of external current generator and electrodes that are placed on the skin to provide the transcutaneous analgesic electrical stimulus to the painful area. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
Physical therapy electrical stimulation system, battery-powered An assembly of battery-powered devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical stimulation of calf muscles to prevent venous thrombosis, and/or to maintain or increase range of motion.
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FDA Product Code

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Product Code Product Code Name
IPF Stimulator, Muscle, Powered
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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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
Height: 5 Inch
Width: 2 Inch
Length: 7.5 Inch
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Device Status

In Commercial Distribution
November 11, 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
10857771003962 40 00857771003965 In Commercial Distribution case
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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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