PERFORMAX PEDIATRIC 1119025

GUDID 30606959007742

PERFORMAX PEDIATRIC EE LEAK 2, SINGLE USE, EXTRA EXTRA SMALL

Respironics, Inc.

CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use
Primary Device ID30606959007742
NIH Device Record Key822eedea-805a-42d2-be7b-5af745fad1f3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERFORMAX PEDIATRIC
Version Model Number00
Catalog Number1119025
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Operating and Storage Conditions

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959007741 [Primary]
GS130606959007742 [Package]
Contains: 00606959007741
Package: Multipack [5 Units]
Discontinued: 1999-12-31
Not in Commercial Distribution

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 Number1
Public Version Date2019-03-12
Device Publish Date2019-03-04

On-Brand Devices [PERFORMAX PEDIATRIC]

30606959014542PerforMax Pediatric, SE, Single Use, Extra Small, Korea
30606959014535PerforMax Pediatric, EE Leak 2, Single Use, Extra Small, Korea
30606959014528PerforMax Pediatric, SE, Single Use, Extra Extra Small, Korea
30606959014511PerforMax Pediatric, EE Leak 2, Single Use, Extra Extra Small, Korea
30606959013606Performax Pediatric, SE, Single Use, Extra Small, China
30606959013590Performax Pediatric EE Leak 2, Single Use, Extra Small, China
30606959013583Performax Pediatric, SE, Single Use, Extra Extra Small, China
30606959013576Performax Pediatric EE Leak 2, Single Use, Extra Extra Small, China
30606959012470PERFORMAX PEDIATRIC EE LEAK 1 ELBOW, SINGLE USE
00606959008069PERFORMAX PEDIATRIC SE, MPU, WITH FOUR POINT HEADGEAR, EXTRA EXTRA SMALL
00606959008052PERFORMAX PEDIATRIC SE, MPU, WITH FOUR POINT HEADGEAR, EXTRA SMALL
00606959008045PERFORMAX PEDIATRIC EE LEAK 2, MPU, WITH FOUR POINT HEADGEAR, EXTRA EXTRA SMALL
00606959008038PERFORMAX PEDIATRIC EE LEAK 2, MPU, WITH FOUR POINT HEADGEAR, EXTRA SMALL
30606959007766PERFORMAX PEDIATRIC SE, SINGLE USE, EXTRA EXTRA SMALL
30606959007742PERFORMAX PEDIATRIC EE LEAK 2, SINGLE USE, EXTRA EXTRA SMALL
30606959007735PERFORMAX PEDIATRIC EE LEAK 2, SINGLE USE, EXTRA SMALL
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.