AccessGUDID - DEVICE: PMRU-S KIT (B25972000)

GUDID

Device Identifier (DI) Information

Brand Name: PMRU-S KIT
Version or Model: 7200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EMERGE DIAGNOSTICS LLC

Primary DI Number: B25972000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078787134 *Terms of Use

Device Description: Electrical diagnostic functional assessment, combining range of motion, functional capacity, and electromyography testing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37794	Electromyography monitor	An electrically-powered device designed to continuously measure electrical signals from a patient’s skeletal muscle and display/record the signals as an electromyograph (EMG) to evaluate brain/nerve function, typically during a surgical procedure. It includes a processing unit with a display intended to be used with EMG leads/electrodes; it may also include data interpretation and/or telemetry features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAL	Exercise Equipment, Powered, Emg-Triggered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123902	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc44d308-3794-4415-b2b1-6abcbdb4db13
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: January 26, 2017