{"operation":"document","citation":"21-0044","title":"Nevro Corp. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2021-06-24","effective_on":null,"summary":"21-0044 response to Nevro Corp. concerning 173.185, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0044.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0044.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0044","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/75336/210044.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nJune 24, 2021\nMr. Calvin Tsai\nManager, Inventory Control and Logistics\nNevro Corp.\n1800 Bridge Pkwy\nRedwood City, CA 94065\nReference No. 21-0044\nDear Mr. Tsai:\nThis letter is in response to your April 21, 2021, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the classification of lithium\nion batteries. Specifically, you ask whether a portable charging device for an implanted medical\ndevice is considered “UN3481, Lithium ion batteries contained in equipment, 9” or “UN3480,\nLithium ion batteries, 9.”\nIn accordance with § 173.22 of the HMR, it is the shipper’s responsibility to properly classify\nand describe a hazardous material. This Office does not perform that function. However,\npursuant to § 173.185 of the HMR, “equipment” means the device or apparatus for which the\nlithium cells or batteries will provide electrical power for its operation. Based on the information\nprovided, the portable charging device would be considered “UN3480, Lithium ion batteries, 9”\nbecause the primary purpose of the portable charging device is to provide electrical power to\nanother device (i.e., the implanted medical device).\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nCiccarone\n21-0044\nFrom: INFOCNTR (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Hazmat Interps\nSubject: FW: Formal letter of interpretation -Nevro\nDate: Thursday, April 22, 2021 4:34:04 PM\nAttachments: UN3481 Shipping Instructions_3-26-2019.pdf\nCHGR2500 Battery MSDS - INR18650.pdf\nCHGR2500 Battery Spec.pdf\nCHGR2500 Rev C (1).docx\nimage002.png\nHi Alice,\nPlease see the below interpretation request.\nIf you have any questions, please do not hesitate to reach out.\nRegards,\n-Breanna\nFrom: Calvin Tsai [mailto:calvin.tsai@nevro.com]\nSent: Wednesday, April 21, 2021 6:04 PM\nTo: PHMSA HM InfoCenter <PHMSAHMInfoCenter@dot.gov>\nSubject: FW: Formal letter of interpretation -Nevro\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or\nopen attachments unless you recognize the sender and know the content is safe.\nHi, someone did reach out to me today, what would it take to get a formal interpretation on this. We\ncan wait the 8 weeks if needed.\nAlso I may have copied down a website wrong can someone reach out to me again?\nThanks!\nCalvin Tsai\nManager, Inventory Control and Logistics\n1800 Bridge Pkwy\nRedwood City, CA 94065\nTel. +(408) 332-2846\ncalvin.tsai@nevro.com\n\n<<<PAGE 3>>>\n\nFrom: Calvin Tsai\nSent: Wednesday, April 21, 2021 10:51 AM\nTo: phmsa.hm-infocenter@dot.gov\nSubject: FW: Formal letter of interpretation -Nevro\nHello,\nCan you confirm we have the correct classification on this product? There is a tiny battery that is\ncontained inside this kit. Please help to review our product and confirm UN3481. Thank you for your\nhelp!\nCalvin Tsai\nManager, Inventory Control and Logistics\n1800 Bridge Pkwy\nRedwood City, CA 94065\nTel. +(408) 332-2846\ncalvin.tsai@nevro.com\nFrom: Calvin Tsai\nSent: Thursday, February 18, 2021 10:01 AM\nTo: phmsa.hm-infocenter@dot.gov\nSubject: RE: Formal letter of interpretation -Nevro\nHello,\nPer our phone conversation, please advise what UN code we need to ship our CHGR devices.\nCurrently we have it as UN3481.\nThanks!\nCalvin Tsai\nManager, Inventory Control and Logistics\n1800 Bridge Pkwy\nRedwood City, CA 94065\nTel. +(408) 332-2846\ncalvin.tsai@nevro.com\n\n<<<PAGE 4>>>\n\nFrom: Calvin Tsai\nSent: Wednesday, February 17, 2021 5:34 PM\nTo: 'phmsa.hm-infocenter@dot.gov' <phmsa.hm-infocenter@dot.gov>\nSubject: Formal letter of interpretation -Nevro\nHello,\nI would like a formal interpretation of one of our products that has lithium ion batteries. Please\nadvise what information you would need from me to have this interpreted correctly.\nThank you!\nCalvin Tsai\nManager, Inventory Control and Logistics\n1800 Bridge Pkwy\nRedwood City, CA 94065\nTel. +(408) 332-2846\ncalvin.tsai@nevro.com","truncated":false,"body_characters":4197}