AccessGUDID - DEVICE: Philips Respironics (00884838025738)

GUDID

Device Identifier (DI) Information

Brand Name: Philips Respironics
Version or Model: V60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U1053617
Company Name: Respironics California, Inc.

Primary DI Number: 00884838025738
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 079550876 *Terms of Use

Device Description: V60 Used Ventilator, English OPT: CFLEX,AVAPS,PPV,AT+

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
MNT	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

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
Special Storage Condition, Specify: Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure: between 600 and 765 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 600 and 765 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53cbd286-fbf1-4b63-ba33-c90f4d3f5d97
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 22, 2015