Travel Compliance Letter for ResMed Therapy Devices
Date: May 3, 2017
Introduction
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 Compliance List
| ResMed product | Product codes |
|---|---|
| AirCurve™ 10 ASV | 37042, 37043, 37044, 37215, 37216, 37229, 37230, 37291, 37410, 37411 |
| AirCurve 10 CS PaceWave™ | 37060, 37061, 37062, 37069, 37070, 37275, 37276, 37277, 37278, 37279, 37280, 37281, 37282, 37283, 37284, 37341, 37354, 37369, 37438 |
| AirCurve 10 S | 37045, 37046, 37047, 37048, 37068, 37213, 37214, 37227, 37228, 37250, 37251, 37290, 37340, 37351, 37397, 37408, 37409 |
| AirCurve 10 ST | 37056, 37057, 37058, 37073, 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, 37211, 37212, 37225, 37226, 37238, 37239, 37248, 37249, 37261, 37262, 37267, 37272, 37289, 37391, 37392, 37406, 37407 |
| AirMini™ AutoSet | 38112, 38113, 38121, 38122, 38139, 38140 |
| AirSense™ 10 AutoSet™ | 37027, 37028, 37029, 37030, 37031, 37032, 37033, 37064, 37065, 37067, 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, 37436 |
| AirSense 10 AutoSet for Her | 37034, 37035, 37036, 37037, 37039, 37040, 37041, 37066, 37209, 37210, 37223, 37224, 37247, 37260, 37288, 37295, 37317, 37318, 37320, 37322, 37328, 37353, 37368, 37390, 37396, 37404, 37405, 37420, 37421, 37422, 37423, 37437 |
| AirSense 10 CPAP | 37014, 37015, 37016, 37017, 37018, 37063, 37072, 37203, 37204, 37217, 37218, 37285, 37311, 37312, 37325, 37395, 37398, 37399, 37440 |
| AirSense 10 Elite | 37019, 37020, 37021, 37022, 37023, 37024, 37025, 37043, 37071, 37205, 37206, 37219, 37220, 37234, 37235, 37243, 37244, 37256, 37265, 37270, 37286, 37313, 37314, 37326, 37338, 37355, 37366, 37371, 37393, 37400, 37401, 37424, 37439 |
| AirSense 10 Respond A | 37416 |
| AirSense 10 Respond W | 37417 |
| AirStart™ 10 APAP | 37008, 37202 |
| AirStart 10 CPAP | 37002, 37201 |
| Astral™ 100 | 27001, 27011, 27012, 27021, 27031, 27032, 27051, 27052, 27061, 27062, 27071, 27072, 27081, 27091, 27918 |
| Astral 150 | 27003, 27013, 27014, 27023, 27033, 27039, 27053, 27054, 27063, 27064, 27068, 27073, 27074, 27083, 27084, 27093 |
| 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, 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, 28308, 28309, 28310, 28311, 28312, 28314 |
| Lumis 150 VPAP ST-A | 28202, 28203, 28204, 28205, 28206, 28207, 28216, 28220, 28222, 28223, 28315, 28316, 28317, 28318, 28320, 28333 |
| ResMed Power Station II (RPS II) | 24921, 24923, 24925, 24926, 24946, 24947, 24959, 24960, 24961, 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, 37072, 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, 36205, 36225, 36245, 36265, 36285, 36305, 36325, 36345, 36365, 36375, 36385 |
| S9 AutoSet 25 | 36106, 36116, 36126, 36146, 36206, 36226, 36366 |
| S9 AutoSet CS | 36100, 36110, 36120, 36140, 36200, 36220, 36240, 36260, 36360 |
| S9 AutoSet CS PaceWave | 36160 |
| 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, 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 |
| 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 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 |
Contact Information
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)
