AccessGUDID - DEVICE: OmniPro System (B62536084000)

GUDID

Device Identifier (DI) Information

Brand Name: OmniPro System
Version or Model: OmniAmp PSG Module
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 360-8400
Company Name: Mays & Asscoiates

Primary DI Number: B62536084000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101772069 *Terms of Use

Device Description: The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
33843	Polysomnograph	A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLV	Standard Polysomnograph With Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050143	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
Height: 3.8 Centimeter
Width: 15.5 Centimeter
Length: 20.5 Centimeter
Weight: 675 Gram

Device Record Status

Public Device Record Key: 6891bc5b-7328-4f28-aeb5-15623378ea93
Public Version Date: December 17, 2019
Public Version Number: 1
DI Record Publish Date: December 09, 2019