ResMed Connectivity Module 27206

GUDID 00619498272068

Connectivity Module (RCM)

RESMED LIMITED

Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing
Primary Device ID00619498272068
NIH Device Record Keye7cc51a0-f174-49be-99d4-46b301733885
Commercial Distribution StatusIn Commercial Distribution
Brand NameResMed Connectivity Module
Version Model Number27206
Catalog Number27206
Company DUNS751149311
Company NameRESMED LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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

Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Degrees Celsius and 95 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498272068 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

Devices Manufactured by RESMED LIMITED

00619498390014 - AIR 112021-07-05 AIRSENSE 11 AUTOSET USA TRI
00619498390021 - AIR 112021-07-05 AirSense 11 CPAP USA CO
00619498390038 - AIR 112021-07-05 AirSense 11 CPAP USA TRI
00619498390045 - AIR 112021-07-05 AirSense 11 Elite USA CO
00619498390052 - AIR 112021-07-05 AirSense 11 Elite USA TRI
00619498393022 - AIR 112021-07-05 AIR 11 FILTER, STD 12 PK
00619498393039 - AIR 112021-07-05 AIR11 FILTER, STD 50 PACK
00619498393046 - AIR 112021-07-05 AIR11 FILTER, HYPO, 1 PACK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.