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Interpretation Response #08-0095 ([OxySure Systems, Inc.] [Mr. John M. Lansdown])

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

Interpretation Response Details

Response Publish Date:

Company Name: OxySure Systems, Inc.

Individual Name: Mr. John M. Lansdown

Location State: TX Country: US

View the Interpretation Document

Response text:

September 17, 2008

Mr. John M. Lansdown

Director of Research

OxySure Systems, Inc.

10880 John W. Elliott Rd., Suite 600

Frisco, TX 75034

Ref. No. 08-0095

Dear Mr. Lansdown:

This is in response to your letter and subsequent telephone conversations with members of my staff regarding the Hazardous Materials Regulations (HMR; 49 CFR 171-180) applicable to chemical oxygen generators. We apologize for the delay in responding and hope it has not caused any inconvenience.

In your letter, you state that your company manufactures a portable chemical oxygen generator, the OxySure Model 615, which delivers medically pure oxygen for use in cardiovascular, respiratory, and general medical emergencies. You state the initiation of oxygen generation is via a mechanical mechanism which releases a plunger. The plunger breaks the internal seals, bringing the oxygen-producing powder and catalyst together in a "slurry." You state that the housing and most of the internal parts are injection-molded plastic, and oxygen is delivered via a latex-free tubing and mask assembly. You ask whether an approval is required for the transportation of your product.

The answer is yes. As currently required in Special Provision 60, a chemical oxygen generator that is shipped with its means of initiation attached must incorporate at least two positive means of preventing unintentional actuation of the generator, and be classed and approved by the Associate Administrator. In addition, the HMR regulations pertaining to a chemical oxygen generator are applicable to your product, including, after October 1, 2008, compliance with

§ 173.168, which includes impact resistance, packaging, and marking requirements.

I hope this satisfies your inquiry.

Sincerely,

Edward T. Mazzullo

Director

Office of Hazardous Materials Standards

173.168

Regulation Sections

Section Subject
173.168 Chemical oxygen generators