Sunrise Medical

Model number 7310PR-D. Serial numbers PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000

General and Plastic Surgery Devices

2

No

Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.

DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.

Model 515ADS - serial number range A561137DS - A562049DS; Model 515ADZ - serial number range A538908DZ - A538924DZ; Model 515AKS - serial number range A542879KS - A543722KS; and Model 515AKZ - serial number A501627KZ.

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including states of AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, and WI, and countries of Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom.

DeVilbiss Model 515A Oxygen Concentrator || Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.

Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.

Anesthesiology Devices

2

No

Worldwide-original shipments to distributors/dealers USA and Canada.

535D-X CF Continuous Flow Cylinder

Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055; Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328; Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922; Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191; Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132; and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267.

Anesthesiology Devices

2

No

Worldwide-original shipments to distributors/dealers USA and Canada.

DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder

serial numbers AD01145 through AD01462

Anesthesiology Devices

2

No

The product was distriubted to 252 end users nationwide through 36 dealers.

DeVilbiss iFill Personal Oxygen Station model number 535D.