21-0044
21-0044
Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 June 24, 2021 Mr. Calvin Tsai Manager, Inventory Control and Logistics Nevro Corp. 1800 Bridge Pkwy Redwood City, CA 94065 Reference No. 21-0044 Dear Mr. Tsai: This letter is in response to your April 21, 2021, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the classification of lithium ion batteries. Specifically, you ask whether a portable charging device for an implanted medical device is considered “UN3481, Lithium ion batteries contained in equipment, 9” or “UN3480, Lithium ion batteries, 9.” In accordance with § 173.22 of the HMR, it is the shipper’s responsibility to properly classify and describe a hazardous material. This Office does not perform that function. However, pursuant to § 173.185 of the HMR, “equipment” means the device or apparatus for which the lithium cells or batteries will provide electrical power for its operation. Based on the information provided, the portable charging device would be considered “UN3480, Lithium ion batteries, 9” because the primary purpose of the portable charging device is to provide electrical power to another device (i.e., the implanted medical device). I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, Dirk Der Kinderen Chief, Standards Development Branch Standards and Rulemaking Division#
Page 2Ciccarone 21-0044 From: INFOCNTR (PHMSA) To: Dodd, Alice (PHMSA) Cc: Hazmat Interps Subject: FW: Formal letter of interpretation -Nevro Date: Thursday, April 22, 2021 4:34:04 PM Attachments: UN3481 Shipping Instructions_3-26-2019.pdf CHGR2500 Battery MSDS - INR18650.pdf CHGR2500 Battery Spec.pdf CHGR2500 Rev C (1).docx image002.png Hi Alice, Please see the below interpretation request. If you have any questions, please do not hesitate to reach out. Regards, -Breanna From: Calvin Tsai [mailto:calvin.tsai@nevro.com] Sent: Wednesday, April 21, 2021 6:04 PM To: PHMSA HM InfoCenter <PHMSAHMInfoCenter@dot.gov> Subject: FW: Formal letter of interpretation -Nevro CAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or open attachments unless you recognize the sender and know the content is safe. Hi, someone did reach out to me today, what would it take to get a formal interpretation on this. We can wait the 8 weeks if needed. Also I may have copied down a website wrong can someone reach out to me again? Thanks! Calvin Tsai Manager, Inventory Control and Logistics 1800 Bridge Pkwy Redwood City, CA 94065 Tel. +(408) 332-2846 calvin.tsai@nevro.com#
Page 3From: Calvin Tsai Sent: Wednesday, April 21, 2021 10:51 AM To: phmsa.hm-infocenter@dot.gov Subject: FW: Formal letter of interpretation -Nevro Hello, Can you confirm we have the correct classification on this product? There is a tiny battery that is contained inside this kit. Please help to review our product and confirm UN3481. Thank you for your help! Calvin Tsai Manager, Inventory Control and Logistics 1800 Bridge Pkwy Redwood City, CA 94065 Tel. +(408) 332-2846 calvin.tsai@nevro.com From: Calvin Tsai Sent: Thursday, February 18, 2021 10:01 AM To: phmsa.hm-infocenter@dot.gov Subject: RE: Formal letter of interpretation -Nevro Hello, Per our phone conversation, please advise what UN code we need to ship our CHGR devices. Currently we have it as UN3481. Thanks! Calvin Tsai Manager, Inventory Control and Logistics 1800 Bridge Pkwy Redwood City, CA 94065 Tel. +(408) 332-2846 calvin.tsai@nevro.com#
Page 4From: Calvin Tsai Sent: Wednesday, February 17, 2021 5:34 PM To: 'phmsa.hm-infocenter@dot.gov' <phmsa.hm-infocenter@dot.gov> Subject: Formal letter of interpretation -Nevro Hello, I would like a formal interpretation of one of our products that has lithium ion batteries. Please advise what information you would need from me to have this interpreted correctly. Thank you! Calvin Tsai Manager, Inventory Control and Logistics 1800 Bridge Pkwy Redwood City, CA 94065 Tel. +(408) 332-2846 calvin.tsai@nevro.com#
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