AccessGUDID - DEVICE: Sleepware (00606959046955)

GUDID

Device Identifier (DI) Information

Brand Name: Sleepware
Version or Model: Sleepware G3 Software, (Japan Only) - 3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1121998
Company Name: Respironics, Inc.

Primary DI Number: 00606959046955
Issuing Agency: GS1
Commercial Distribution End Date: March 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Software, Sleepware G3 (Japan Only)

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?
47567	Polysomnography analyser	A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLZ	Automatic event detection software for polysomnograph with electroencephalograph

FDA Premarket Submission

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

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: c23b2ea2-a0b2-4ab5-956a-f3939ba47b36
Public Version Date: March 05, 2021
Public Version Number: 3
DI Record Publish Date: January 03, 2018