AccessGUDID - DEVICE: BiPAP System One 60 Series (00606959005969)

GUDID

Device Identifier (DI) Information

Brand Name: BiPAP System One 60 Series
Version or Model: BiPAP Pro BiFlex, w/HT Humid System One 60 Series, US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS660TS
Company Name: Respironics, Inc.

Primary DI Number: 00606959005969
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, 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?
60712	Home BPAP 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 bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. 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 -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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: 43b8aff4-e83b-47a2-b48e-cf7c79c3cea3
Public Version Date: January 28, 2021
Public Version Number: 3
DI Record Publish Date: August 20, 2016