WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10 8-100795-00

GUDID 30884838075642

RESPIRONICS NOVAMETRIX, LLC

Home CPAP unit
Primary Device ID30884838075642
NIH Device Record Key584aa25e-37fe-49d6-8e72-1ba871b544b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhisperPak, 7.5cmH2O - 22mm CPAP, Case 10
Version Model Number00
Catalog Number8-100795-00
Company DUNS093608594
Company NameRESPIRONICS NOVAMETRIX, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM
Phone+1(203)697-6450
EmailOEM.RESPIRONICS@PHILIPS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838075641 [Primary]
GS130884838075642 [Package]
Contains: 00884838075641
Package: Multipack [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, breathing, positive end expiratory pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-12
Device Publish Date2017-09-01

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