Kawasumi Laboratories Thailand Co L T D

FDA Filings

This page includes the latest FDA filings for Kawasumi Laboratories Thailand Co 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 Number: 9615908
• FEI Number: 3003282181
• Name: KAWASUMI LABORATORIES (THAILAND) CO., LTD.
• Owner & Operator: KAWASUMI LABORATORIES, INC.
• Contact Address: SHINAGAWA INTERCITY TOWER B 2-15-2, KONAN,; MINATO-KU JP-13 Tokyo 108-6109 JP
• Official Correspondent:
  • Katsu - Furuya
  • 81-3-57692664-x
• US Agent:
  • RONALD D.ARKIN
  • ARKIN CONSULTING GROUP, LLC
  • 770 5656166
  • 678 8948320
  • RONARKIN@ARKINCONSULTING.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 48 MU 8, RATCHASIMA-CHOK CHAI RD, TAMBON THA ANG, AMPHOE; CHOK CHAI Nakhon Ratchasima, 30190 TH
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K102994 | FMI KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR	2011-01-07
PMN K102994 | FMI KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD ADVANTAGE PHELEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR WITH PREATTACHED 16 GAUGE VEINPUNCTURE NEEDLE AND 16	2011-01-07
PMN K102994 | FMI KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD ADVANTAGE BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTOR	2011-01-07
PMN K102890 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter	2011-01-07
PMN K102890 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K Shield Advantage Small Vein Infusion Set	2011-01-07
PMN K100720 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K Shield Port Access Infusion Set with High Pressure Tubing	2011-01-07
PMN K994323 | LHI KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI LABORATORIES PHLEBOTOMY SET	2008-03-03
PMN K994323 | KSB KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI LABORATORIES PHLEBOTOMY SET	2008-03-03
PMN K935505 | FMI KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER	2008-03-03
PMN K896896 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	SMALL VEIN INFUSION SET	2008-03-03
PMN K896896 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI SMALL VEIN INFUSION SET	2008-03-03
PMN K060580 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD PORT ACCESS INFUSION SET	2008-03-03
PMN K060580 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD PORT ACCESS INFUSION SET WITH ANTINEEDLE STICK PROTECTOR	2008-03-03
PMN K030385 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECTOR NEEDLELESS ACCESS CONNECTOR	2008-03-03
PMN K030385 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADD-ON FILTER ADMINISTRATION SET WITH .22 MICRON FILTER	2008-03-03
PMN K023917 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR	2008-03-03
PMN K023917 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	K-SHIELD WINGED COLLECTIONS SET WITH MULTIPLE SAMPLE LUER ADAPTER	2008-03-03
PMN K001426 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER	2008-03-03
PMN K001426 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADMINISTRATION SET WITH .22 MICRON FILTER	2008-03-03
PMN K001426 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADMINISTRATION SET WITH .22 MICRON FILTER, NEEDLELESS ACCESS CONNECTOR	2008-03-03
PMN K001424 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD	2008-03-03
PMN K001424 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADMINISTRATION SET	2008-03-03
PMN K001424 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADMINISTRATION SET WITH NEEDLELESS ACCESS CONNECTOR	2008-03-03
PMN K001424 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV ADMINISTRATION SET SECONDARY ADMINISTRATION SET	2008-03-03
PMN K001423 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	IV Administration Set Primary Set with Backcheck Valve, Needleless Access Connector	2008-03-03
PMN K001423 | FPA KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	ADMINISTRATION SET, PRIMARY	2008-03-03
PMN K921901 | FRN KAWASUMI LABORATORIES (THAILAND) CO., LTD. [KAWASUMI LABORATORIES, INC.]	KAWASUMI PORT ACCESS INFUSION SET	2008-01-09