AccessGUDID - DEVICE: REMstar System One 60 Series (00606959005495)

GUDID

Device Identifier (DI) Information

Brand Name: REMstar System One 60 Series
Version or Model: REMstar Auto A-Flex, with Humidifier, 60 Series, AU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU561HS
Company Name: Respironics, Inc.

Primary DI Number: 00606959005495
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: REMstar Auto A-Flex, with Humidifier, System One 60 Series, Australia

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?
60711	Home CPAP unit	A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 254879f3-74c0-4e16-8f60-e3077af9748b
Public Version Date: October 31, 2022
Public Version Number: 6
DI Record Publish Date: August 20, 2016