BiPAP autoSV Advanced System One 60 Series

Basic Information

• Brand Name: BiPAP autoSV Advanced System One 60 Series
• Primary DI: 00606959014237
• Version / Model: BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CA
• Catalog Number: CA961TS
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 4
• Public Version Date: 2022-10-31
• Public Version Status: Update
• Public Device Record Key: 191ff1b3-58da-4306-8328-175b731961b8
• Distribution End Date: 2022-10-28

Device Description

BiPAP autoSV Advanced System One 60 Series with Heated Tube Humidifier, Canada

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959014237	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius