Pro-Teh 1097346

GUDID 40606959032352

PRO-FLOW MULTIPURPOSE NASAL CANNULA, 0.35x.35

Respironics, Inc.

Polysomnograph
Primary Device ID40606959032352
NIH Device Record Key45600775-042e-4478-afd2-135797d4cd4b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Teh
Version Model NumberPRO-FLOW
Catalog Number1097346
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 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(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959032354 [Primary]
GS130606959032355 [Package]
Contains: 00606959032354
Package: Multipack [60 Units]
Discontinued: 1999-12-31
Not in Commercial Distribution
GS140606959032352 [Package]
Contains: 00606959032354
Package: Multipack [10 Units]
Discontinued: 1999-12-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLVStandard polysomnograph with electroencephalograph

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 Date2016-10-05

Devices Manufactured by Respironics, Inc.

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00606959424951 - DreamStation BiPAP AVAPS2025-08-12 DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia
00606959424968 - DreamStation BiPAP AVAPS2025-08-12 DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
00606959424975 - DreamStation BiPAP AVAPS2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia
00606959424982 - DreamStation BiPAP AVAPS2025-08-12 DreamStation BiPAP AVAPS30 AE with WiFi, Australia
00606959424999 - DreamStation BiPAP AVAPS2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
00606959425378 - DreamStation2025-08-12 DreamStation BiPAP AVAPS 30 AAM with Humidifier and Heated Tube, no Bluetooth, China

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