Mindray DS USA, Inc., dba Datascope Patient Monitoring

Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.

Anesthesiology Devices

2

No

Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.

AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; || A Mindray Global Company. || The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

Product numbers 0998-00-3024-01.

Anesthesiology Devices

2

No

Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA

Datascope AS3000 Anesthesia System; || Mindray, North America. || The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.

All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200)  2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits:  0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.

Anesthesiology Devices

2

No

Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.

SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). || Probe Cover for use with the SmarTemp Reusable Temperature Probe.

All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200)  2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits:  0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.

Cardiovascular Devices

2

No

Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.

SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). || Probe Cover for use with the SmarTemp Reusable Temperature Probe.

Part Number 6100F: Domestic Serial Numbers: PV 02018-K9, PV02024-K9, PV02039-K9, PV01999-K9, PV02004-K9, PV02017-K9, PV02020-K9, PV01687-I9, PV01694-I9, PV01702-I9, PV02325-K9, PV02043-K9, PV01403-I9, PV01509-I9, PV01675-I9, PV02229-K9, PV02011-K9, PV02045-K9, PV02044-K9, PV02037-K9, PV02300-K9, PV01412-I9, PV01411-I9 and PV01695-I9; and  Foreign Serial Numbers: PV01470-I9, PV01924-J9, PV0926-J9, PV01989-K9, PV01994-K9, PV01997-K9, PV02330-K9, PV02332-K9, PV02744-A0, PV03005-A0, PV03006-A0, PV03007-A0, PV01965-K9, PV01970-K9, PV01971-K9, PV02056-K9 and PV02057-K9.

Cardiovascular Devices

2

No

Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.

Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. || Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.