Devices

Passport V Monitor

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.
Product Description
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.
Manufacturer
Mindray DS USA, Inc., dba Datascope Patient Monitoring
1 Event
- Recall of Passport V Monitor

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer Address
Mindray DS USA, Inc., dba Datascope Patient Monitoring, 800 Macarthur Blvd, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
Source
USFDA

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