Philips Respironics 1053616

GUDID 00884838020047

V60 Ventilator, English Opt: None

Respironics California, Inc.

Portable electric ventilator

Primary Device ID	00884838020047
NIH Device Record Key	4a9c2b0c-0f23-4e05-a1e6-1041e9d5bf78
Commercial Distribution Status	In Commercial Distribution
Brand Name	Philips Respironics
Version Model Number	V60
Catalog Number	1053616
Company DUNS	079550876
Company Name	Respironics California, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com
Phone	1-800-345-6443
Email	respironics.service@philips.com

Operating and Storage Conditions

Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep dry, do not stack more than 3 high
Storage Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 600 KiloPascal and 765 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838020047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K082660

FDA Product Code

MNT	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-22

On-Brand Devices [Philips Respironics]

00884838025738	V60 Used Ventilator, English OPT: CFLEX,AVAPS,PPV,AT+
00884838020054	V60 Ventilator, English,Opt: CFLEX,AVAPS
00884838020047	V60 Ventilator, English Opt: None