AccessGUDID - DEVICE: MicroSnore™ (10816843021327)

GUDID

Device Identifier (DI) Information

Brand Name: MicroSnore™
Version or Model: 300530
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROCHESTER ELECTRO-MEDICAL, INC.

Primary DI Number: 10816843021327
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 068156330 *Terms of Use

Device Description: MICROSNORE SNORING MICROPHONE: 1.25" MICROPHONE DIAMETER, 6 FT. (1.8 M) WIRE

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):	Yes
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?
36548	Patient monitoring system module, electrocardiographic/respiratory	A small unit dedicated to the measurement of the electrical activity of the heart in the form of an electrocardiogram (ECG) and to follow patient respiration patterns to identify episodes of arrhythmia and/or apnoea also derived from the ECG. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the electrocardiographic/respiratory information.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, Breathing Frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0299d89a-1526-4a07-b9f3-3d065d836f0b
Public Version Date: May 21, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016