AccessGUDID - DEVICE: BiPAP autoSV Advanced System One 60 Series (00606959027756)

GUDID

Device Identifier (DI) Information

Brand Name: BiPAP autoSV Advanced System One 60 Series
Version or Model: BiPAP autoSV Advanced w/H Tube Humid, 60 Series, US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DS960XTS
Company Name: Respironics, Inc.

Primary DI Number: 00606959027756
Issuing Agency: GS1
Commercial Distribution End Date: July 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: BiPAP autoSV Advanced with Heated Tube Humidifier, 60 Series, 30cm, USA

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?
47083	Portable electric ventilator	A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).	Active	false

FDA Product Code

[?]

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

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 57b3a7d5-ed40-4a65-a97e-6199fec93e9c
Public Version Date: July 28, 2023
Public Version Number: 4
DI Record Publish Date: August 25, 2016