{"operation":"document","citation":"09-0155","title":"Inogen, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-08-06","effective_on":null,"summary":"09-0155 response to Inogen, Inc. concerning 173.185, 173.21.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0155.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0155.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0155","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090155.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\nAl'\" i; ;igg\n1200 New Jersey Ave., SE\nWashington, DC 20590\nMr. Matt Scribner\n' Inogen, Inc.\nBollay Drive\nGoleta, CA 93 1 17\nRef. No. 09-0155\nDear Mr. Scribner:\nThis responds to your July 6,2009 letter requesting clarification of the applicability of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 17 1-1 80) to a portable oxygen\nconcentrator. You request confirmation that the Inogen One G2 portable oxygen concentrator\nis not subject to the HMR.\nYour company previously requested an interpretation in 2004 on the applicability of the\nHMR to the Inogen One portable oxygen concentrator. In our ~ a r ' c h 24,2004 letter\nresponding to your request, we stated that the device is not subject to the HMR provided the\ndevice is packaged in conformance with fj 173.21 (c).\nAccording to your letter, your company has made design improvements to Inogen One,\nwhich will be marketed as Inogen One G2. The new version includes an optional 24-ceI1\nlithium ion battery pack to power the device consisting of two independent 12-cell battery\npacks. Each 12-cell battery pack operates independently in the same manner as the 12-cell\nbattery pack that was used to power Inogen One. Specifically, the battery packs are\nelectrically isolated and mechanically separated when enclosed in the device. Your letter\nalso indicates that: (1) each lithium ion celI has an equivalent lithiuin content of 0.66 gram;\n(2) the total equivalent lithium content of each 12-cell battery pack is 7.92 grams; (3) the\nbatteries are contained in the device and packaged in a manner to prevent sparks or the\ngeneration of a dangerous evolution of heat; (4) the pressure of the oxygen in the device is\nless than 40.6 psia at 20 OC (68 OF); (5) and no other hazardous material subject to the HMR\nis contained in the device.\nYou should be aware that since our March 24, 2004 letter, we have amended the HMR\nprovisions applicable to lithium batteries, including the exceptions for small and medium\nlithium batteries. In a final rule published August 9,2007, under Dockets HM-224C and\nHM-224E (72 FR 44930; copy enclosed), we relocated the exceptions for small lithium\nbatteries in fj 173.185(b) to Special Provision 188 in fj 172.102(~)(1). In addition, we\nremoved the exception for medium lithium batteries for transported by air, including the\nexception for batteries up to 25 grams aggregate lithium content when fully charged.\nFurther, we added a new provision, beginning October 1,2009, that small lithium cells and\nbatteries must be of a type proven to meet the performance standards for applicable tests in\nthe UN Manual of Tests and Criteria.\n\n<<<PAGE 2>>>\n\nBased on the information provided, the oxygen in the Inogen One G2 portable oxygen\nconcentrator is not subject to the HMR as a Division 2.2 non-flammable gas. Moreover, it is\nthe opinion of this Office that the Inogen One G2 portable oxygen concentrator described in\nyour letter and the lithium ion batteries contained in the device conform to the provisions of\nSpecial Provision 188. Therefore, provided the provisions in Special Provision 188 continue\nto be met, the Inogen One G2 portable oxygen concentrator is not subject to any other\nrequirements in the HMR.\nThe approval of the Federal Aviation Administration (FAA) is required before portable\noxygen concentrators may be used by passengers onboard aircraft. The FAA published a\nfinal rule on July 12,2005 (70 FR 40155; copy enclosed) regarding these devices. For\nfurther assistance, you may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA\nAir Carrier Operations Branch (AFS-220) by phone at (202)-267-3732 or email at\ndavid.catev@,faa.gov. In addition, even with FAA approval, an air carrier ultimately\ndetermines what may or may not be carried on its aircraft. We suggest that you check with\nthe airlines to ensure that the Inogen One G2 portable oxygen concentrator may be carried.\nI hope this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nSincer ly,\n91.1.\nEnclosure:\n1. August 9, 2007 Final Rule: \"Hazardous Materials; Transportation of Lithium Batteries\"\n2. July 12, 2005 Final Rule: \"Use of Certain Portable Oxygen Concentrator Devices\nOnboard Aircraft\"\n\n<<<PAGE 3>>>\n\nU.S. Department of Transportation 4 / 7 3 . 185\nPipeline and Hazardous Materials Safety Administration $ f7X. 161\nOffice of Hazardous Materials Standards\n1200 New Jersey Avenue, SE\nWashington, DC 20590-0001\nDear Sir or Madam,\nEnclosed is a submission to receive a confirmation from the Pipeline and\nHazardous Materials Safety Administration that the new version of the Inogen\nOne portable oxygen concentrator, which was the first concentrator to be\napproved by the FAA for use on commercial aircraft, continues to meet\nspecifications allowing its use on aircraft.\nWe are aggressively attempting to make the FAA Regulatory Committee meeting\nscheduled for the 3rd week of July and need this confirmation in order to complete\nthe package.\nIt is extremely important to Inogen, as this is our only product, that the updated\nversion have the FAA approval upon its release in September.\nPlease contact me if you have any questions. I greatly appreciate your assistance\nin reviewing our changes.\nSincerely,\nMatt Scribner\nVP of Operations\nInogen, Inc.\nBollay Drive\nGoleta, CA 93 1 17\nPhone: (805) 562-0528\nFax: (805) 562-05 16\nCell: (805) 252-5089\nE-mail: mscribner@inogen.net\n\n<<<PAGE 4>>>\n\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration Office of Hazardous Materials Standards\n1200 New Jersey Avenue, SE 173. \\ 8 5\nIcc,b(l 1'5\nWashington, DC 20590-0001 b4 -0I55\nDear Sir or Madam,\nInogen is requesting written confirmation from the Pipeline and Hazardous Materials\nSafety Administration (PHMSA) that the Inogen One G2 Portable Oxygen Concentrator\nis not subject to the U.S. Hazardous Materials Regulation (HMR) under HMR; 49 CFR\nParts 100- 180 after review of all appropriate information.\nInogen manufactures portable oxygen concentrators (POC) and has had the Inogen\nOne available for commercial distribution since receiving 5 10(k) clearance from\nFDA on May 13,2004. The Inogen One POC is currently allowed to be used\nonboard aircraft and was added to the SFAR No. 106 in the final published\nregulation on July 12,2005. As part of that application, Mr. Mazzullo of the U.S.\nDepartment of Transportation sent a letter to Inogen stating that the Inogen One\nPOC is not subject to the HMR.\nInogen Inc. has made design improvements to the Inogen One, which will be\nmarketed as the Inogen One G2 Portable Oxygen Concentrator. The changes to the\nInogen One are minor, but should help the user's mobility by providing increased\nbattery life (2-4 hours), a smaller, lighter-weight device (less than 7 pounds),\nreduced noise, and an increase in the maximum rate of oxygen production (up to\n900 mllmin). The Inogen One G2 has an optional 24-cell battery consisting of two\nindependent 12-cell battery packs, rather than a single battery pack. Each pack\noperates independently with the exact same operating specifications as the single\n12-cell battery pack in the previously-approved Inogen One. This additional\naccessory option avoids the patient's need to carry two separate batteries on the\naircraft.\nThe Inogen One and the Inogen One G2 provide oxygen in the same manner, by\nseparating oxygen from ambient air utilizing a molecular sieve and pressure swing\nadsorption methodology. The resultant concentrated oxygen is accumulated in an\noxygen reservoir for delivery to the patient. This pressure in the Inogen One G2 is\ncontrolled in the same manner as the Inogen One to limit the pressure to less than\n40.6 psia maximum. Both Inogen POCs deliver oxygen to the patient through the\n\n<<<PAGE 5>>>\n\nthe ruling that the Inogen Portable Oxygen Concentrator is not subject to the\nHazardous Material Regulation.\nInogen asks that the PHMSA confirm that the Inogen One G2 Portable Oxygen\nConcentrator is not subject to the U.S. Hazardous Materials Regulation under\nHMR 49 CFR Parts 100- 180.\nPlease call or email if you have any questions. I can be reached at (805) 252-5089\nor by email at mscribner@inogen.net\nThank you for your attention.\nSincerely,\nMatt Scribner\nVP of Operations\nInogen, Inc.\nBollay Drive\nGoleta, CA 93 1 17\nPhone: (805) 562-0528\nFax: (805) 562-05 16\nCell: (805) 252-5089\nE-mail: mscribner@,inogen.net","truncated":false,"body_characters":8476}