Nene Labs — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 400 Seventh St., S.W. Washington, D.C. 20590 Research and special Programs Administration MAY 1 1 2004 Mr. Jeff Jerome Ref. No.: 03-0303 CEO - Nene Labs 5115 Gage Boise, Idaho 83706 Dear Mr. Jerome: This responds to your letter regarding the classification and shipment of a portable "OX-GEN Flexible 02 Generation System, Model 6-0X-03," containing a water solution of approximately 7.5 % hydrogen peroxide by weight and manganese oxide, as a catalyst, in accordance with the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). The OX-GEN Flexible 02 Generation System is intended to produce oxygen for emergency uses. The OX-GEN Flexible 02 Generation System delivers over 8 liters per minute of 99% pure oxygen for a minimum of 15 minutes by means of a follows: chemical reaction. The portable oxygen generator system is composed of two parts, described as The reaction vessel consists of a plastic bag, with two chambers separated by a weak seal. The weak seal is welded plastic which breaks at about 10 pounds of pressure achieved by squeezing the bag toward the weak seal. The bag contains an outlet of chemically non-reactive tygon tubing attached to the hydrophobic filter. The bag (reaction vessel) reached a maximum average pressure of 4.2 Ibs/psi. The hydrophobic filter is not reactive with hydrogen peroxide or oxygen, and allows O2 (oxygen) gas to pass, but no liquid, and leads to a standard oxygen mask. The chemicals in the reaction vessel consists of a water solution of approximately 7.5% H,Oz (hydrogen peroxide) by weight in one chamber, and a small amount of MnO, (manganese dioxide) in the smaller chamber. The MinOz is a catalyst in the reaction, and liberates one of the oxygen molecules from the Hl,Oz, yielding H2O (water) and O2 (oxygen). Since the reaction is exothermic, heat is generated. At the end of the reaction, the temperature of the reactants is approximately 68°C - 72°C. The maximum temperature of the O½ at the end of the reaction is 32°C - 34°C. After the reaction is complete (less than 20 minutes), the entire apparatus is thrown away. The final by-products at the end of the reaction are water and manganese dioxide. All components in this system are designed for single use only. 173.22 030303#

Page 2Based on the information you provided, it is this Office's opinion that a water solution of approximately 7.5 % hydrogen peroxide by weight does not meet the definition in § 173.127 as a Division 5.1 (Oxidizer). The manganese oxide (principal reactant) may be an oxidizer if data or experience indicates that it meets the definition in § 173.127 as a Division 5.1 (Oxidizer). As defined in § 171.8 of the HMR, an oxygen generator (chemical means a device containing chemicals that upon activation releases oxygen as a product of chemical reaction. A device that meets the definition in § 171.8 for an "Oxygen generator (chemical)," must be described on a shipping paper as "Oxygen generator, chemical, 5.1, UN 3356, PG II," and all other applicable rules of the HMR would apply. with its means of initiation attached must incorporate at least two positive means of preventing In § 172.102, Special Provision 60 specifies that a chemical oxygen generator that is shipped unintentional actuation of the generator, and be classed and approved by the Associate Administrator for Hazardous Materials Safety. Procedures for filing for an approval request are found in Subpart H of Part 107 of the HMR. Each person who offers a chemical oxygen generator for transportation must: (1) ensure that it is offered in conformance with the conditions of the approval; (2) maintain a copy of the approval at each tacility where the chemical oxygen generator is packaged; and (3) mark the approval number on the outside of the package. For example, since the product is designed to be flexibly operable with very light pressure breaking the membrane between the activating catalyst and the reactant hydrogen peroxide solution, preventing unintentional activation may necessitate that the soft flexible pouch be enclosed in a rigid container for transportation. Transportation of a chemical oxygen generator is forbidden on passenger-carrying aircraft. A spent, chemical oxygen generator is forbidden on passénger-carrying and cargo-only aircraft. Special Provision A51 specifies that when transported by cargo-only aircraft, an oxygen generator must conform to the provisions of Special Provision 60 and be contained in a packaging prepared and originally offered for transportation by the approval holder. I hope this satisfies your inquiry. If we can be of further assistance, please contact us. Office of Hazardous Materials Standards#

Page 3Engrum NENE LABS $173.22 an! Pharmar cubical se Pedoperor of the Family Shippers Responsibility 03-0303 November 12, 2003 Edward Mazzullo 400 7* Street South West USDOT/RSPA, DHIM-10 Washington, DC 20590-0001 Mr. Mazzullo, Our sales representative (Jeff Morris) talked with you two weeks ago in regards to getting a hazardous materials qualification from you on a product we are developing for OX-GEN. lere is a draft of our 510 (k) for the FDA. Hopefully it is detailed enough or vou to deterpine if our product will be considered lazardous Material. *ni Featulations Please let me know what we need to do next to get the classification. Thank you for your time, Soak and Heati Bath Tablets wize Aloe Siff Jerome -Jeff Jerome Jeff Jerome jlerome@nenelabs.com Alex Thompson AThompson@nenelabs.com (866) 588-7644 "..: Fax: (877) 553-7663 » 5115 Gage 5: 5 :#