Jw Icu Medical L T D

FDA Filings

This page includes the latest FDA filings for Jw Icu Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008496528
FEI Number3008496528
NameDennis Bassett
Owner & OperatorJW ICU Medical Limited
Contact Address68 Dalian Road
Wei Hai CN-37 Shandong 264209 CN
Official Correspondent
  • Chun Guang - Yu
  • 86-631-5655290-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address457 W Virginia Ave
Punta Gorda, FL 33950 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number8043983
FEI Number3002806593
NameBioptimal International Pte. Ltd.
Owner & OperatorJW ICU Medical Limited
Contact Address68 Dalian Road
Wei Hai CN-37 Shandong 264209 CN
Official Correspondent
  • Chun Guang - Yu
  • 86-631-5655290-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address36 Jalan Tukang
SINGAPORE South West, 619266 SG
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Dennis Bassett [JW ICU Medical Limited]
Thermodilution Catheter and2010-07-26
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Thermodilution Catheter and2010-07-26
Dennis Bassett [JW ICU Medical Limited]
and Accessories2010-01-07
Dennis Bassett [JW ICU Medical Limited]
Thermodilution Catheter2010-01-07
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
and Accessories2010-01-07
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Thermodilution Catheter2010-01-07
Dennis Bassett [JW ICU Medical Limited]
Bioport System2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Bioport System2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Biotrans? Pressure Monitoring Kits2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Biotrans? Pressure Monitoring Kits2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Biotrans? Reusable Sensor Base2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Biotrans? Reusable Sensor Base2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Biosensors Embolectomy Catheter2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Biosensors Embolectomy Catheter2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Safetywedge? Relief2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Safetywedge? Relief2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Heparin Coated Thermodilution2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Catheter and Accessories2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Heparin Coated Thermodilution2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Catheter and Accessories2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Pressure Monitoring System2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Accutrans? Disposable2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Pressure Monitoring System2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Accutrans? Disposable2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Inline Sensor Assembly and2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Inline Sensor Assembly and2007-11-29
Dennis Bassett [JW ICU Medical Limited]
Biosensors Central Venous Catheter2007-11-29
Bioptimal International Pte. Ltd. [JW ICU Medical Limited]
Biosensors Central Venous Catheter2007-11-29

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