Pixi Pediatric Mask

GUDID 09353645610303

Pixi Pediatric Mask - AMER

RESMED ASIA PTE. LTD.

CPAP/BPAP nasal mask, reusable
Primary Device ID09353645610303
NIH Device Record Keycd69108e-e29c-4487-980b-31bcf190a0d8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePixi Pediatric Mask
Version Model Number61030
Company DUNS659298251
Company NameRESMED ASIA PTE. LTD.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS109353645610303 [Primary]

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 Date2025-05-08
Device Publish Date2025-04-30

Devices Manufactured by RESMED ASIA PTE. LTD.

09353645610303 - Pixi Pediatric Mask2025-05-08Pixi Pediatric Mask - AMER
09353645610303 - Pixi Pediatric Mask2025-05-08 Pixi Pediatric Mask - AMER
09353645401048 - Oxyensure Mounting Straps2023-07-31 Oxyensure POC Mounting Straps (AMO)
09353645350520 - External Battery Assembly2023-04-04 Mobi External Battery
09353645000098 - Charger AC/DC with power cord2021-07-22 Activox, Charger AC/DC with power cord
09353645350537 - AC/DC Charger US2021-07-22 AC/DC Charger US (AMO)
09353645401062 - Oxyensure AC/DC Charger US2021-07-22 Oxyensure POC AC/DC Charger US (AMO)
09353645000562 - Mobi2021-01-18 Mobi - Refurbished
09353645000104 - Charger DC/DC2020-04-20 Activox, Charger DC/DC

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