DreamStation Humidifier, ES PR ESXHPR

GUDID 00606959049796

DreamStation Humidifier, Spain (Praxair unit)

Respironics, Inc.

Heated respiratory humidifier
Primary Device ID00606959049796
NIH Device Record Keye57d8722-4fd6-4aca-8e27-9a986da26835
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamStation Humidifier, ES PR
Version Model Number00
Catalog NumberESXHPR
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com
Phone+1 724-387-4000
EmailRespironics.Service@philips.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959049796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-19

Devices Manufactured by Respironics, Inc.

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00606959417540 - DreamStation2022-01-10 Micro-Flexible Heated 12mm Tube
00606959060135 - Therapy Mask 31002021-12-16 Medium Wide, Therapy Mask 3100 Silicone
00606959060098 - Therapy Mask 31002021-11-04
00606959060104 - Therapy Mask 31002021-11-04
00606959060128 - Therapy Mask 31002021-11-04
00606959063082 - DreamStation 22021-11-04
00606959063228 - DreamStation 22021-11-04

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