{"operation":"document","citation":"10-0241","title":"Oxus, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2010-12-17","effective_on":null,"summary":"10-0241 response to Oxus, Inc. concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0241.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0241.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0241","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100241.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration\n1200 New Jersey Ave, SE\nWashington, D.C. 20590\nDEC 172010\nMrs. Joan Rolwing\nOxus, Inc.\n1685 Northfield Dr.\nRochester Hills, MI 48309\nRef. No.: 10-0241\nDear Mrs. Rolwing:\nThis responds to your November 5, 2010 letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to lithium battery requirements.\nYou indicate that your company, Oxus, Inc., has purchased the design, process, inventory, and\nall rights to the Delphi Medical Systems device \"Portable Oxygen Concentrator, Model RS00400.\"\nIn 2008, Delphi Medical Systems requested a letter of interpretation from this Office\npertaining to whether this product complied with Special Provision 188 and was not otherwise\nsubject to the HMR (08-0034). Specifically, you ask if PHMSA will reconfirm whether this\nproduct is in compliance with the HMR.\nIn your letter, dated 11/5/2010, you indicate the Oxus, Inc. \"Portable Oxygen Concentrator,\nModel RS-00400\" and external battery module continues to meet the following criteria:\n(1) the pressure of the oxygen in the device does not exceed 40.6 psia at 20°C;\n(2) the cells contain not more than 1.5 grams of lithium equivalent content;\n(3) the lithium ion batteries contain an aggregate equivalent lithium content of not more than\n8g;\n(4) the device contains no other materials subject to the HMR; and\n(5) the batteries are fully contained in equipment and packaged in a manner to preclude sparks\nor the generation of a dangerous quantity of heat.\nBased on the information above, the Oxus, Inc. portable oxygen concentrator and external\nbattery module meet Special Provision 188. Provided they continue to meet the requirements\nestablished by Special Provision 188, you are not otherwise subject to the HMR.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nI~~~~~-~-\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nNovember 5, 2010 Oxus, Inc.\n1685 Northfield Dr. Rochester Hills, MI 48309\nNItke~\ng 113. 18b\n-3 111· ) DZ S~ 188\n,LiM/uM ~ #Cries\n//)-tJ:2~1\nOffice ofHazardous Materials Standards\nU.S. DOTIPHMSA (PHH-IO)\n1200 New Jersey Avenue, SE East building, 2nd Floor\nWashington, DC 20590\nAttention: Mr. Edward T. Mazzullo, Director\nMr. Mazzullo,\nIn July of2008, you issued the attached response to Delphi Medical Systems confirming the non-hazardous\nstatus ofthe Delphi Medical Systems Portable Oxygen Concentrator (POC) Model RS-00400. In 2010,\nOxus America, (also operating under a DBA ofOxus, Inc.), purchased the design, process, inventory and\nall rights to the Delphi Medical Systems Portable Oxygen Concentrator.\nOxus is preparing for launch and is requesting a confirmation that the Portable Oxygen Concentrator Model\nRS-00400, now to be marketed by Oxus, Inc. is not subject to the HMR.\nI can confirm that the Model RS-00400 and the external battery module continue to meet the following\ncriteria:\n1) the pressure of the oxygen in the device does not exceed 40.6 psia at 20 deg C;\n2) the cells contain not more than 1.5 grams of lithium equivalent content;\n3) the lithium ion batteries contain an aggregate equivalent lithium content of not more than 8g;\n4) the device contains no other materials subject to the HMR; and\n5) the batteries are fully contained in equipment and packaged in a manner to preclude sparks or the\ngeneration of a dangerous quantity of heat.\nBased on Special Provision 188, we are requesting a reconfirmation of the letter of interpretation issued to\nDelphi Medical to be provided to Oxus, Inc. to assure we are in compliance with the HMR and associated\nstandards prior to shipment. I will contact your office next week to understand ifthere is any additional\ninformation you may need to facilitate the request.\nThank you in advance,\nJoan Rolwing\nOxus, Inc.\n249-410-1194\nAttachments: I) Letter of Interpretation to Delphi Medical","truncated":false,"body_characters":4032}