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Interpretation Response #21-0044

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Nevro Corp.

Individual Name: Calvin Tsai

Location State: CA Country: US

View the Interpretation Document

Response text:

June 24, 2021

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

173.22, 173.185

Regulation Sections

Section Subject
173.185 Lithium cells and batteries
173.22 Shipper's responsibility