BiPAP ST 1061T

GUDID 00606959039186

BiPAP ST C-Series International 30 FGD SA

Respironics, Inc.

Portable electric ventilator
Primary Device ID00606959039186
NIH Device Record Keyc471afe7-91ba-4826-b404-e52309c1d9a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiPAP ST
Version Model Number00
Catalog Number1061T
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)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959039186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

On-Brand Devices [BiPAP ST]

00606959022010BiPAP ST C Series Core Pack Heated Tube AHP
00606959021969BiPAP ST C-Series Core Package AHP
00606959021952BiPAP ST C-Series, AHP
00606959021884BiPAP ST C Series, ND 30
00606959015845BiPAP ST C Series Core Pack, Heated Tube, China
00606959015753BiPAP ST C Series Core Package China
00606959015746BiPAP ST C Series, China
00606959012561BiPAP ST C Series Core Pack, Heated Tube
00606959012554BiPAP ST C Series Core Package
00606959012547BiPAP ST C Series - Domestic
00606959043718BiPAP ST C Series, Spain
00606959043695BiPAP ST C Series, Sweden 30
00606959043671BiPAP ST C Series, PT 30
00606959043657BiPAP ST C Series, NO 30
00606959043633BiPAP ST C Series, Great Britain 30
00606959043619BiPAP ST C Series, Finland 30
00606959039278BiPAP ST 20, FGD SA
00606959039209BiPAP ST C-Series China FGD SA
00606959039193BiPAP ST C-Series France 30, FGD SA
00606959039186BiPAP ST C-Series International 30 FGD SA
00606959039179BiPAP ST C-Series International FGD SA 30 PL
00606959039162BiPAP ST C Series International 25 FGD SA
00606959039155BiPAP ST C-Series 30, FGD SA Domestic
00606959039148BiPAP ST C Series, International, Italy 30
00606959039131BiPAP ST 20
00606959039100BiPAP ST C Series, International 30
00606959039094BiPAP ST C Series, International
00606959039070BiPAP ST C Series, French 30
00606959039056BiPAP ST, Harmony
00606959025028BiPAP ST C Series, ZA 30
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