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Travel Compliance Letter

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0% found this document useful (0 votes)
134 views4 pages

Travel Compliance Letter

Faltu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Page 1 of 4

May 26, 2022


Travel Compliance Letter for ResMed Therapy Devices

To whom it may concern,

ResMed respiratory assistive devices (ventilators, respirators, and CPAP machines) are medical devices
prescribed for use on or by the order of a physician and are cleared for sale by the U.S. Food and Drug
Administration, a branch of the Federal Government of the United States of America, and the Australian
Therapeutics Goods Administration.

The devices do not contain any parts or materials known to cause or interfere with the safe operation of a
commercial aircraft.

The U.S. Department of Transportation (DOT) Final Rule, “Non-discrimination on the Basis of Disability in Air
Travel” (73 FR 27614 which updates Title 14 CFR Part 382), effective May 13, 2009, provides important new
requirements for the accommodation of passengers with respiratory assistive devices.

Specifically, respiratory assistive devices may be used on board an aircraft, without further testing by the
carrier, provided they have been tested for electromagnetic compatibility (EMC) in accordance with the current
version of RTCA/DO-160, Section 21, Category M.

ResMed has successfully completed testing for the respiratory assistive devices described in this letter. The
devices listed below comply with RTCA/DO-160G, Section 21, Category M, and are considered FAA
compliant. This information may be engraved on the device or a sticker label applied to the device; either
method for identifying FAA compliance is acceptable and in accordance with DOT regulations.

ResMed product Product codes


AirCurve™ 10 ASV 37042, 37043, 37044, 37092, 37215, 37216, 37229, 37230, 37291,
37410, 37411
AirCurve 10 CS 37060, 37061, 37062, 37069, 37070, 37114, 37275, 37276, 37277,
PaceWave™ 37278, 37279, 37280, 37281, 37282, 37283, 37284, 37341, 37354,
37369, 37438, 37459
Aircurve 10 CS-A 28281
Aircurve 10 CS-A 28282,28283, 28284
PaceWave™
Aircurve 10 CS-A TJ 28280
AirCurve 10 S 37045, 37046, 37047, 37048, 37068, 37093, 37213, 37214, 37227,
37228, 37250, 37251, 37290, 37340, 37351, 37397, 37408, 37409
AirCurve 10 ST 37056, 37057, 37058, 37073, 37095, 37306, 37307, 37348, 37349,
37373, 37374, 37375, 37412, 37413
AirCurve 10 ST-A 28210, 28211, 28219, 28323, 28326
AirCurve 10 VAuto 37050, 37051, 37052, 37053, 37054, 37055, 37059, 37094, 37109,
37211, 37212, 37225, 37226, 37238, 37239, 37248, 37249, 37261,
37262, 37267, 37272, 37289, 37391, 37392, 37406, 37407, 37481
AirMini™ AutoSet 38112, 38113, 38119, 38121, 38122, 38139, 38140, 38145

ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92123 USA ▪ T 1 800 424 0737 ▪ F 1 858 836 5000
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ▪ T +61 (2) 8884 1000 ▪ F +61 (2) 8884 2000
ResMed (UK) Ltd 8 Wimpole Street, London W1G 9SP, UK ▪ T +44 (1235) 862 997 ▪ F +44 (1235) 831 336
[Link]
109120/19 2018-6
Page 2 of 4

ResMed product Product codes


AirSense™ 10 AutoSet™ 37027, 37028, 37029, 37030, 37031, 37032, 37033, 37064, 37065,
37067, 37090, 37101, 37102, 37207, 37208, 37221, 37222, 37236,
37237, 37245, 37246, 37254, 37258, 37259, 37266, 37271, 37273,
37274, 37287, 37294, 37315, 37316, 37319, 37321, 37327, 37339,
37352, 37367, 37372, 37402, 37403, 37415, 37436, 37453, 37457
AirSense 11 AutoSet 39000, 39001, 39140, 39141, 39163, 39180, 39181, 39190, 39191
AirSense 10 AutoSet for Her 37034, 37035, 37036, 37037, 37039, 37040, 37041, 37066, 37091,
37104, 37105, 37209, 37210, 37223, 37224, 37247, 37260, 37288,
37295, 37317, 37318, 37320, 37322, 37328, 37353, 37368, 37390,
37396, 37404, 37405, 37420, 37421, 37422, 37423, 37430, 37434,
37437, 37454, 37458
AirSense 10 CPAP 37014, 37015, 37016, 37017, 37018, 37063, 37072, 37088, 37203,
37204, 37217, 37218, 37285, 37311, 37312, 37325, 37395, 37398,
37399, 37440, 37461
AirSense 11 CPAP 39002, 39003
AirSense 10 Elite 37019, 37020, 37021, 37022, 37023, 37024, 37025, 37043, 37071,
37089, 37118, 37205, 37206, 37219, 37220, 37234, 37235, 37243,
37244, 37256, 37265, 37270, 37286, 37313, 37314, 37326, 37338,
37355, 37366, 37371, 37393, 37400, 37401, 37424, 37425, 37439,
37455, 37460
AirSense 11 Elite 39004, 39005, 39142, 39143, 39162, 39179
AirSense 10 Respond A 37416
AirSense 10 Respond W 37417
AirStart™ 10 APAP 37008, 37009, 37202, 37241, 37365
AirStart 10 CPAP 37002, 37004, 37201, 37240, 37364, 37370
Astral™ 100 27001, 27011, 27012, 27021, 27031, 27032, 27051, 27052, 27061,
27062, 27071, 27072, 27081, 27082, 27091
Astral 150 27003, 27013, 27014, 27023, 27033, 27039, 27053, 27054, 27063,
27064, 27068, 27073, 27074, 27083, 27084, 27088, 27093, 27094
Astral External Battery 27918, 27919
Climate Control kit 36875, 36876, 36905, 36915, 36917
LifeChoice Activox™ POC XYC100, XYC100A, XYC100RA, XYC100RB, XYC102R, XYC100B,
XYC100B-PRO, XYC100B-SPT, XYC100B-P4L, 200122
Lumis 100 VPAP S 28001, 28002, 28003, 28004, 28005, 28006, 28007, 28008, 28009,
28010, 28011, 28012, 28013, 28302, 28303, 28304, 28322
Lumis 100 VPAP ST 28101, 28102, 28103, 28104, 28105, 28106, 28107, 28108, 28109,
28306, 38305, 38307
Lumis 100 VPAP ST-A 28201, 28221, 28313, 28332
Lumis 150 VPAP ST 28110, 28111, 28112, 28113, 28114, 28115, 28116, 28117, 28118,
28119, 28120, 28121, 28122, 28123, 28124, 28125, 28308, 28309,
28310, 28311, 28312, 28314

ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92123 USA ▪ T 1 800 424 0737 ▪ F 1 858 836 5000
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ▪ T +61 (2) 8884 1000 ▪ F +61 (2) 8884 2000
ResMed (UK) Ltd 8 Wimpole Street, London W1G 9SP, UK ▪ T +44 (1235) 862 997 ▪ F +44 (1235) 831 336
[Link]
109120/19 2018-6
Page 3 of 4

ResMed product Product codes


Lumis 150 VPAP ST-A 28202, 28203, 28204, 28205, 28206, 28207, 28216, 28220, 28222,
28223, 28226, 28315, 28316, 28317, 28318, 28320, 28333
Mobi 35001, 35003, 35004, 35005, 35006, 35009, 35013
POC External Battery 35052
ResMed Power Station II 24921, 24923, 24925, 24926, 24946, 24947, 24959, 24960, 24961,
(RPS II) 24962, 24963, 24964, 24981, 24990, 36821, 36822, 36823, 36824,
37342, 37343
S8™ Auto 25 26104, 26105, 26125, 26126
S8 AutoScore II 33044
S8 AutoSet 33105, 33138
S8 AutoSet II 33129, 33141, 33150
S8 AutoSet Spirit 19423, 19426, 33113, 33121, 33122, 33123, 33124, 33125, 33126
S8 AutoSet Spirit II 33130, 33131, 33132, 33133, 33134, 33135, 33136, 33143, 33144,
33145, 33146, 33147, 33148
S8 AutoSet Vantage 19420, 33112
S8 Elite 19413, 19414, 33021, 33026, 33027, 33028, 33031
S8 Compact 19404, 33030
S8 Elite II 33039, 33040, 33041, 33042, 33043, 33045, 33062, 33072, 33073,
33074, 33075
S8 Escape™ 19405, 19408, 19409, 19410, 33001, 33002, 33003, 33007, 33009,
33013, 33024, 33036, 33060
S8 Escape II 33048, 33051, 33052, 33053, 33054, 33061, 33064
S8 Lightweight 33032
S8 Lightweight II 33055
S8 Respond 33128, 33137
S9™ AutoSet 36005, 36015, 36025, 36084, 36085, 36086, 36087, 36088, 36089,
36095, 36105, 36115, 36125, 36145, 36180, 36185, 36205, 36225,
36245, 36265, 36285, 36305, 36325, 36345, 36365, 36375, 36385
S9 AutoSet 25 36106, 36116, 36126, 36146, 36206, 36226, 36266, 36296, 36366
S9 AutoSet CS 36100, 36110, 36120, 36140, 36200, 36220, 36240, 36260, 36360
S9 AutoSet CS PaceWave 36160, 36170
S9 AutoSet CS-A 36211, 36351, 36390
S9 AutoSet for Her 36015, 36065, 36075
S9 Elite 36003, 36013, 36023, 36083, 36093, 36103, 36113, 36123, 36143,
36183, 36203, 36223, 36243, 36263, 36303, 36343, 36363, 36373
S9 Escape 36001, 36011, 36021, 36081, 36091, 36121, 36141, 36201, 36221,
36261, 36301, 36361
S9 Escape Auto 36002, 36012, 36022, 36092, 36122, 36302, 36362

ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92123 USA ▪ T 1 800 424 0737 ▪ F 1 858 836 5000
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ▪ T +61 (2) 8884 1000 ▪ F +61 (2) 8884 2000
ResMed (UK) Ltd 8 Wimpole Street, London W1G 9SP, UK ▪ T +44 (1235) 862 997 ▪ F +44 (1235) 831 336
[Link]
109120/19 2018-6
Page 4 of 4

ResMed product Product codes


S9 VPAP™ Adapt 36007, 36017, 36027, 36037, 36047, 36057, 36097, 36367, 36377
S9 VPAP Adapt SV 26008, 26009, 26011, 26013, 26928
S9 VPAP Adapt SV-A 36331
S9 VPAP Auto 36006, 36016, 36026, 36096
S9 VPAP S 36004, 36014, 36024, 36094, 36114, 36124, 36144, 36204, 36224,
36244, 36264, 36284, 36304
S9 VPAP ST 36008, 36018, 36028, 36098, 36108, 36118, 36128, 36148, 36208,
36228, 36248, 36368, 36378
S9 VPAP ST-A 36009, 36039, 36049, 36059, 36099, 36119, 36129, 36159, 36169,
36209, 36219, 36239, 36339, 36359, 36379
Sleepmate 10 Auto 37418
Sleepmate 10 Elite 37419
Stellar™ 100 24151, 24152, 24153, 24154, 24155, 24156, 24157, 24158, 24159,
24163, 24164, 24166, 24168, 24170
Stellar 130 24172
Stellar 150 24140, 24141, 24142, 24143, 24144, 24145, 24146, 24147, 24149,
24160, 24161, 24162, 24165, 24167, 24169
VPAP IV 26102, 26103, 26106, 26107, 26108, 26109, 26123, 26127
VPAP IV ST 26112, 26113, 26114, 26115, 26116, 26117, 26118, 26124
VPAP Auto 25 26101, 26111, 26121
VPAP S 26119, 26120
VPAP ST 26110, 26122

Not all products are available in each country/region. Please check with your regional representative for
specific country availability.

Please contact ResMed Customer Service with any questions.

Australia: +61 (2) 8884 1000, 1800 658 189 (Toll free)
New Zealand: +0800 737 633 (Toll free)
United Kingdom: +44 (1235) 862 997
EU, France: +33 (0) 1 60 183 600
United States: +1 (800) 424 0737 (Toll free)

Kind regards,

Sheila Bruschi
Director, Regulatory Affairs
[Link]@[Link]

ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92123 USA ▪ T 1 800 424 0737 ▪ F 1 858 836 5000
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ▪ T +61 (2) 8884 1000 ▪ F +61 (2) 8884 2000
ResMed (UK) Ltd 8 Wimpole Street, London W1G 9SP, UK ▪ T +44 (1235) 862 997 ▪ F +44 (1235) 831 336
[Link]
109120/19 2018-6

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