Interpretation Response #04-0053 ([Inogen Inc] [Mr. Robert S. Fary])

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

Interpretation Response Details

Response Publish Date: 03/24/2004

Company Name: Inogen Inc

Individual Name: Mr. Robert S. Fary

Location State: CA Country: US

View the Interpretation Document

Response text:

Mar 24, 2004

Mr. Robert S. Fary                Reference No. 04-0053
Inogen Inc.
Vice President of Sales
120 Cremona Drive, Suite B
Goleta, CA 93117

Dear Mr. Fary:

This is in response to your letter dated March 10, 2004, regarding the applicability of the Department of Transportation’s Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a device that your company calls the Inogen One portable oxygen concentrator.

The Inogen One portable oxygen concentrator is a device which separates oxygen from room air for delivery to patients who require supplemental oxygen therapy.  It can be powered by multiple power sources, including a 12 cell rechargeable lithium ion battery, an AC power pack, and an automobile cigarette lighter adapter.  The total equivalent lithium content of the battery pack is 7.92 grams and each cell of the battery pack has an equivalent lithium content of 0.66 grains.  The process by which oxygen is separated is called pressure swing adsorption.  This process utilizes a small air compressor, valves, and controlling electronics to pass air across a material called a molecular sieve.  The material acts as a filter to nitrogen and passes the oxygen to the patient.  The operating pressure of this device is approximately 39 psia.  The oxygen concentrator contains no other hazardous material that is subject to the HMR.

Based on the information above, the Inogen One portable oxygen concentrator is not subject to the HMR because: (1) the pressure of the oxygen in the device never exceeds 40.6 psia at 68 EF; (2) the lithium ion battery used to operate the device is excepted from the HMR; and (3) the portable oxygen concentrator contains no other material subject to the HMR.  Though the lithium ion battery is excepted from the HMR it must satisfy the requirements of § 173.21 (c) which states that an electrical device is forbidden for transportation unless it is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals).

I hope this satisfies your request.

Sincerely,

Edward T. Mazzullo
Director, Office of Hazardous
Materials Standards

173.115

Regulation Sections