Kawasumi Laboratories America Inc

FDA Filings

This page includes the latest FDA filings for Kawasumi Laboratories America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1055927
FEI Number1000113359
NameKAWASUMI LABORATORIES AMERICA, INC.
Owner & OperatorKAWASUMI LABORATORIES, INC.
Contact AddressSHINAGAWA INTERCITY TOWER B 2-15-2, KONAN,
MINATO-KU JP-13 Tokyo 108-6109 JP
Official Correspondent
  • Katsu - Furuya
  • 81-3-57692664-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address10002 PRINCESS PALM AVENUE, SUITE 324
Tampa, FL 33619 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR2011-01-07
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD ADVANTAGE PHELEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR WITH PREATTACHED 16 GAUGE VEINPUNCTURE NEEDLE AND 162011-01-07
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD ADVANTAGE BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTOR2011-01-07
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter2011-01-07
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K Shield Advantage Small Vein Infusion Set2011-01-07
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K Shield Port Access Infusion Set with High Pressure Tubing2011-01-07
KAWASUMI LABORATORIES AMERICA, INC.
K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)2010-10-21
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI LABORATORIES PHLEBOTOMY SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI LABORATORIES PHLEBOTOMY SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
INTERMITTENT INJECTION SITE2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
INTERMITTENT INJECTION SITE2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
SMALL VEIN INFUSION SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI SMALL VEIN INFUSION SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD PORT ACCESS INFUSION SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD PORT ACCESS INFUSION SET WITH ANTINEEDLE STICK PROTECTOR2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECTOR NEEDLELESS ACCESS CONNECTOR2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADD-ON FILTER ADMINISTRATION SET WITH .22 MICRON FILTER2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
K-SHIELD WINGED COLLECTIONS SET WITH MULTIPLE SAMPLE LUER ADAPTER2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADMINISTRATION SET WITH .22 MICRON FILTER2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADMINISTRATION SET WITH .22 MICRON FILTER, NEEDLELESS ACCESS CONNECTOR2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADMINISTRATION SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADMINISTRATION SET WITH NEEDLELESS ACCESS CONNECTOR2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV ADMINISTRATION SET SECONDARY ADMINISTRATION SET2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
IV Administration Set Primary Set with Backcheck Valve, Needleless Access Connector2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
ADMINISTRATION SET, PRIMARY2008-03-03
KAWASUMI LABORATORIES AMERICA, INC. [KAWASUMI LABORATORIES, INC.]
KAWASUMI PORT ACCESS INFUSION SET2008-01-09
KAWASUMI LABORATORIES AMERICA, INC.
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR2003-04-15
KAWASUMI LABORATORIES AMERICA, INC.
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER2000-07-21
KAWASUMI LABORATORIES AMERICA, INC.
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD2000-07-21
KAWASUMI LABORATORIES AMERICA, INC.
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY2000-07-21
KAWASUMI LABORATORIES AMERICA, INC.
KAWASUMI LABORATORY BLOOD DRAWING KIT2000-05-19

Related Finance Registrations
NCAGE Code0YWM7KAWASUMI LABORATORIES AMERICA INC
CAGE Code0YWM7KAWASUMI LABORATORIES AMERICA INC
DUNS626918015Kawasumi Laboratories America, Inc.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091512702Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT3628 CTN
2020091012940Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT8244 CTN
2020091012940Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT8244 CTN
2020090919510Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT8244 CTN
2020090919510Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT8244 CTN
2020090112818Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT2631 CTN
2020082410683Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT3284 CTN
2020081711547Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT1423 CTN
202008145974Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT3187 CTN
202008068718Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT6180 CTN
202008068718Laem Chabang,Thailand -> Savannah, GeorgiaMULTIPLE BLOOD COLLECTION KIT6180 CTN
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