ResMed Travel Compliance Letter for Respiratory Assistive Devices
Introduction
Date: February 8, 2024
To: Whom it may concern
This letter confirms that ResMed respiratory assistive devices, including ventilators, respirators, and CPAP machines, are medical devices prescribed by a physician and cleared for sale by the U.S. Food and Drug Administration and the Australian Therapeutics Goods Administration. These devices do not contain any parts or materials known to cause or interfere with the safe operation of a commercial aircraft.
Regulatory Compliance for Air Travel
In accordance with the U.S. Department of Transportation (DOT) Final Rule, “Non-discrimination on the Basis of Disability in Air Travel" (73 FR 27614, Title 14 CFR Part 382), effective May 13, 2009, respiratory assistive devices may be used on board an aircraft. For such use, devices must be 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 listed in this letter. These devices comply with RTCA/DO-160G, Section 21, Category M, and are considered FAA compliant. This compliance information may be engraved on the device or provided on a sticker label applied to the device, both methods being acceptable in accordance with DOT regulations.
ResMed Product Compliance List
| ResMed Product | Product Codes |
|---|---|
| AirCurve™ 10 ASV | 37042, 37043, 37044, 37092, 37215, 37216, 37229, 37230, 37291, 37410, 37411, 37384, 37144 |
| AirCurve 10 CS PaceWave™ | 37060, 37061, 37062, 37069, 37070, 37114, 37275, 37276, 37277, 37278, 37279, 37280, 37281, 37282, 37283, 37284, 37341, 37354, 37369, 37438, 37459, 28517, 28516 |
| AirCurve 11 ASV | 39012, 39013, 39023 |
| AirCurve 11 VAuto | 39018, 39019, 39020 |
| Aircurve 10 CS-A | 28281 |
| Aircurve 10 CS-A PaceWave™ | 28282,28283, 28284 |
| 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, 37116, 37107 |
| AirCurve 10 ST | 37056, 37057, 37058, 37073, 37095, 37306, 37307, 37348, 37349, 37373, 37374, 37375, 37412, 37413, 37385, 37145, 37111 |
| AirCurve 10 ST-A | 28210, 28211, 28219, 28323, 28326, 28285, 28340 |
| 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, 37450, 37481, 37383, 37143, 37110, 37108, 37164 |
| AirMini™ AutoSet | 38112, 38113, 38119, 38121, 38122, 38139, 38140, 38145, 38151 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, 37445, 37448, 37453, 37457, 37382, 37142, 37497, 37496, 37122, 37503, 37146, 37147, 37504, 37505, 37147, 37103, 37106, 37126, 37160, 37493 39000, 39001 |
| AirSense™ 10 AutoSet™ | 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, 37445, 37448, 37453, 37457, 37382, 37142, 37497, 37496, 37122, 37503, 37146, 37147, 37504, 37505, 37147, 37103, 37106, 37126, 37160, 37493 39000, 39001 |
| AirSense 11 AutoSet | 39420, 39463, 399466, 3991480,399483,39948533048,83B05117393903,930108, |
| AirSense 11 Auto | 39520, 39315 |
| 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, 37446, 37449, 37454, 37458, 37494 |
| AirSense 10 CPAP | 37014, 37015, 37016, 37017, 37018, 37063, 37072, 37088, 37203, 37204, 37217, 37218, 37285, 37311, 37312, 37325, 37395, 37398, 37399, 37440, 37461, 37497 |
| AirSense 11 CPAP | 39002, 39003, 39421 |
| 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, 37444, 37455, 37460, 37495, 37424, 37117, 37100, 37124 |
| AirSense 11 Elite | 39004, 39005, 39142, 39143, 39162, 39179, 39422, 39481, 39482, 39461, 39106, 39107 |
| AirSense 10 Respond A | 37416 |
| AirSense 10 Respond W | 37417 |
| AirSense 11 Respond | 39317 |
| 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 27003, 27013, 27014, 27023, 27033, |
| Astral 150 | 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, 28502 |
| Lumis 100 VPAP ST | 28101, 28102, 28103, 28104, 28105, 28106, 28107, 28108, 28109, 28306, 38305, 38307, 28505 |
| Lumis 100 VPAP ST-A | 28201, 28221, 28313, 28332, 28513 |
| 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, 28506, 28507, 28508, 28509 |
| Lumis 150 VPAP ST-A | 28202, 28203, 28204, 28205, 28206, 28207, 28208, 28216, 28220, 28222, 28223, 28226, 28315, 28316, 28317, 28318, 28320, 28333, 28314, 28512, 28515, 28514 |
| Lumis HFT | 28401 |
| Mobi | 35001, 35003, 35004, 35005, 35006, 35009, 35013 |
| POC External Battery | 35052 |
| 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 19420, 33112 19413, 19414, 33021, 33026, 33027, |
| S8 AutoSet Vantage | 33028, 33031 19404, 33030 33039, 33040, 33041, 33042, 33043, 33045, 33062, 33072, 33073, 33074, 33075 |
| S8 Elite | 19405, 19408, 19409, 19410, 33001, 33002, 33003, 33007, 33009, 33013, 33024, 33036, 33060 |
| S8 Compact | 33048, 33051, 33052, 33053, 33054, 33061, 33064 |
| S8 Elite II | 33032 |
| S8 Escape™ | 33055 |
| S8 Escape II | 33128, 33137 |
| S8 Lightweight | 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 |
| S8 Lightweight II | 36106, 36116, 36126, 36146, 36206, 36226, 36266, 36296, 36366 |
| S8 Respond | 36100, 36110, 36120, 36140, 36200, 36220, 36240, 36260, 36360 |
| S9™ AutoSet | 36160, 36170 |
| S9 AutoSet 25 | 36211, 36351, 36390 |
| S9 AutoSet CS | 36009, 36039, 36049, 36059, 36099, 36119, 36129, 36159, 36169, 36209, 36219, 36239, 36339, 36359, 36379 |
| S9 AutoSet CS PaceWave | 36004, 36014, 36024, 36094, 36114, 36124, 36144, 36204, 36224, 36244, 36264, 36284, 36304 36008, 36018, 36028, 36098, 36108, 36118, 36128, 36148, 36208, 36228, 36248, 36368, 36378 |
| S9 AutoSet CS-A | 36007, 36017, 36027, 36037, 36047, 36057, 36097, 36367, 36377 |
| S9 AutoSet for Her | 36015, 36065, 36075 36003, 36013, 36023, 36083, 36093, 36103, 36113, 36123, 36143, 36183, |
| S9 Elite | 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 36008, 36018, 36028, 36098, 36108, 36118, 36128, 36148, 36208, 36228, 36248, 36368, 36378 |
| S9 VPAP ST | 36009, 36039, 36049, 36059, 36099, 36119, 36129, 36159, 36169, 36209, 36219, 36239, 36339, 36359, 36379 |
| S9 VPAP ST-A | 37418 |
| Sleepmate 10 Auto | 39318 |
| Sleepmate 11 Auto | 37419 |
| Sleepmate 10 Elite | 24151, 24152, 24153, 24154, 24155, 24156, 24157, 24158, 24159, 24163, 24164, 24166, 24168, 24170 24172 24140, 24141, 24142, 24143, 24144, |
| Stellar™ 100 | 24145, 24146, 24147, 24149, 24160, |
| Stellar 130 | 24161, 24162, 24165, 24167, 24169 |
| Stellar 150 | 26102, 26103, 26106, 26107, 26108, 26109, 26123, 26127 |
| VPAP IV | 26112, 26113, 26114, 26115, 26116, 26117, 26118, 26124 |
| VPAP IV ST | 26101, 26111, 26121 |
| VPAP Auto 25 | 26119, 26120 |
| VPAP S | 26110, 26122 |
| VPAP ST |
Contact Information and Signatory
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 W1G9SP, UK T +44 (1235) 862 997 F +44 (1235) 831 336
ResMed.com
Kind regards,
Sheila Bruschi
Director, Regulatory Affairs
Sheila.bruschi@resmed.com
