DreamStation Go Heated Humidifier WEGH

GUDID 00606959055896

DreamStation Go Heated Humidifier, Western Europe

Respironics, Inc.

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

Primary Device ID	00606959055896
NIH Device Record Key	8dda0317-1a21-49c2-8bbb-d1814d3d3b23
Commercial Distribution Status	In Commercial Distribution
Brand Name	DreamStation Go Heated Humidifier
Version Model Number	WEGH
Catalog Number	WEGH
Company DUNS	080728314
Company Name	Respironics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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

Operating and Storage Conditions

Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959055896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131982

FDA Product Code

BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-13
Device Publish Date	2019-06-05

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