AirFit X30i

GUDID 00619498643547

AIRFIT X30I SML STPK AMER - SLM

RESMED PTY LTD

CPAP/BPAP face mask, reusable
Primary Device ID00619498643547
NIH Device Record Key8705660b-9c15-4ab2-a905-2b6d22488195
Commercial Distribution StatusIn Commercial Distribution
Brand NameAirFit X30i
Version Model Number64354
Company DUNS751149311
Company NameRESMED PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498003006 [Direct Marking]
GS100619498643547 [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 Date2024-12-17
Device Publish Date2024-12-09

On-Brand Devices [AirFit X30i ]

00619498643561AirFit X30i LGE STPK AMER - SLM
00619498643554AIRFIT X30I STD STPK AMER - SLM
00619498643547AIRFIT X30I SML STPK AMER - SLM
00619498643509AirFit X30i LGE STPK AMER
00619498643011AIRFIT X30I STD STPK AMER
00619498643004AIRFIT X30I SML STPK AMER

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