Stored Energy Concepts, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Washington, D.C. Research and special Programs Administration AUG 1 2 1999 Mr. Richard E. Lisowski Ref. No. 99-0116 Stored Energy Concepts, Inc. P.O. Box 387 St. Peters, PA 19470-0387 Dear Mr. Lisowski: This is in response to your letter dated May 3, 1999 and telephone conversation with a member of my staff, regarding small quantity exceptions under the Hazardous Materials Regulations: (HMR; 49 CFR Parts 171-180). Specifically you ask if your device classified as "Life-saving appliances, not self-inflating, Class 9, UN3072" may be shipped under the small quantity exception in $ 173.4. The answer is no. The 30 gram quantity limitation in § 173.4 (a) (1) (ii) applies to the life saving appliance, not just the explosive component. Your life saving appliance, which was classified under an approval (EX9707049) as a Class 9, weighs more than 30 grams. The lifesaving appliance may only be shipped under the small quantity exception if the entire device meets the quantity limitations of 30 grams in § 173.4 (a) (1) (ii). I hope this satisfies your request. Sincerely, Transportation Regulations Specialist Office of Hazardous Materials Standards 173.4 990116 ....#

Page 2I Stored Energy 99-0116 Concepts, Anc.. May 3, 1999 U.S. Department of Transportation 400 Seventh Street S.W. Washington, D.C. 20590 Standards Division DHM-10 Room 8104 To Whom it may concern: an exemption.for their product in accordance with part 107.105 of.49CFR. LIFECOR manufactures a LIFECOR, INC. of 121 Freeport Rd, Pittsburgh, PA has retained my services with regard to applying for new cardiac defibrillator which is currently under FDA evaluation: The defibrillator, which is worn by the Classification Code 9, EX9707049, namely a Moditied WCD Electrode Belt: Assembly, LIFECOR part patient like a vest, has been classified as a Life Saving: Appliance (not self inflating), UN3072, U.N. : number 10A0265-AO. Each WCD belt assembly contains a maximum quantity of 0.18 grams of LIFECOR and patients or physicians. During my research of 49: CFR, I came across a small quantity hazardous material. The Class 9 designation causes logistical problems in shipping to and from exception, 173.4 of 49CFR. Therefore, this letter is in reference to obtaining clarification of section 173.4 of 49 CFR, Small quantity per package not to exceed 30 grams in accordance with section173.4 and obtains package Quantities Exception. It is my understanding of this section that if one follows the limits for small testing in accordance with 173.4 and marks the packaging in accordance with 173.4; then a Life Saving Appliance (not self inflating) UN3072 U.N. Classification Code 9, EX9707049, namely a Modified WCD Electrode Belt Assembly LIFECOR part number 10A0265-A0, may be offered for private or commercial in 173.4. Could you please advise me in writing as to whether or not have made the correct shipment subject to no other requirements in the Hazardous Materials Regulations beyond those stated interpretation of this section? Thank you for your consideration of this matter. Sincerely, This trut Richard E. Lisowski President Stored Energy Concepts, Inc. P.O. Box 387, St. Peter's, Pa 19470-0387 Phone: (610) 469-6543 Fax: (610) 469-6547#