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SB-KAWASUMI LABORATORIES, INC.

US

Last updated May 30, 2026

Part of Sb-Kawasumi Laboratories, Inc.

What SB-KAWASUMI LABORATORIES, INC. makes

The company manufactures single-use medical devices for vascular access, intravenous therapy, and endoscopic procedures. These include infusion sets for port-access administration, intravenous administration sets with and without integrated filters, blood collection sets (both invasive and noninvasive), and endoscopic accessories such as hoods and monopolar electrosurgical electrodes. Surgical retractors designed for hand-held use are also part of the portfolio.

The portfolio comprises Class I and Class II devices, regulated under the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s UDI database, adhering to U.S. regulatory requirements for medical devices. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does SB-Kawasumi Laboratories, Inc. manufacture?

SB-Kawasumi Laboratories, Inc. specializes in single-use medical devices primarily for vascular access, intravenous therapy, and endoscopic procedures. Their portfolio includes vascular port administration sets for infusions, intravenous administration sets (both invasive and noninvasive), blood collection sets (invasive and noninvasive), endoscopic hoods, monopolar electrosurgical electrodes, and hand-held surgical retractors. These devices are designed to support critical clinical workflows in various medical settings.

Where is SB-Kawasumi Laboratories, Inc. based, and how does that affect its regulatory compliance?

SB-Kawasumi Laboratories, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including the Unique Device Identification (UDI) system. The company’s products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. medical device requirements. This registration helps healthcare providers and regulators identify and verify the devices in clinical use.

Which regulatory registries or databases list SB-Kawasumi Laboratories, Inc.’s devices?

SB-Kawasumi Laboratories, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system assigns a unique identifier to each device, enabling better tracking, transparency, and compliance with U.S. regulatory standards. This database helps healthcare professionals and authorities verify the devices’ details, such as manufacturer information, device descriptions, and regulatory classifications.

How are SB-Kawasumi Laboratories, Inc.’s devices classified under FDA regulations?

SB-Kawasumi Laboratories, Inc.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification determines the regulatory oversight required for each device, ensuring appropriate safety and effectiveness standards are met before they enter the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
kawasumiamerica.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
(813) 630-5554
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
690625850

Catalogue (275)

Page 1 of 6
DeviceModel / ReferenceRegistriesClassStatus
Port Access Infusion Set PI01Y01
FDA UDI
Class IIActive
Port Access Infusion Set PI03091
FDA UDI
Class IIActive
Iv Add-On Filter Administration Set With .22 Micron Filter IV-F02Y
FDA UDI
Class IIActive
Port Access Infusion Set PI02Y01
FDA UDI
Class IIUnknown
SB Soft Hood /Straight type MD-47950
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02Y00
FDA UDI
Class IIUnknown
K-Shield Advantage Winged Blood Collection Set With Pre-Attached Holder DBMH-21G
FDA UDI
Class IIActive
Port Access Infusion Set PI06021
FDA UDI
Class IIUnknown
K-Shield Advantage Small Vein Infusion Set D3KA-27G
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y20
FDA UDI
Class IIActive
K-Shield Advantage Winged Blood Collection Set With Pre-Attached Holder DBMH-23G
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01N01
FDA UDI
Class IIUnknown
IV ADMINISTRATION SET with Needleless Access Connector IV-013N
FDA UDI
Class IIUnknown
Port Access Infusion Set PI06090
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04090
FDA UDI
Class IIUnknown
Port Access Infusion Set PI02000
FDA UDI
Class IIUnknown
Iv Administration Set With .22 Micron Filter IV-025Y
FDA UDI
Class IIActive
Port Access Infusion Set PI05021
FDA UDI
Class IIUnknown
Port Access Infusion Set PI04090
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03020
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03091
FDA UDI
Class IIUnknown
Port Access Infusion Set PI04000
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03001
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02N90
FDA UDI
Class IIUnknown
Port Access Infusion Set PI04020
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA01N90
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA04000
FDA UDI
Class IIActive
Port Access Infusion Set PI02Y00
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA01N21
FDA UDI
Class IIActive
Port Access Infusion Set PI04091
FDA UDI
Class IIActive
Port Access Infusion Set PI01Y00
FDA UDI
Class IIActive
Port Access Infusion Set PI04001
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH01X01
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01001
FDA UDI
Class IIUnknown
Port Access Infusion Set PI02Y20
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y03
FDA UDI
Class IIActive
Iv Administration Set IV-016Y
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03090
FDA UDI
Class IIActive
Port Access Infusion Set PI03021
FDA UDI
Class IIActive
Port Access Infusion Set PI03001
FDA UDI
Class IIActive
SB Soft Hood /Straight type MD-47970
FDA UDI
Class IIActive
K-Shield Advantage Small Vein Infusion Set D3KA-23G
FDA UDI
Class IIActive
Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder MBCH-01
FDA UDI
Class IIActive
K-Shield Advantage Winged Blood Collection Set With Pre-Attached Holder DBMH-25G
FDA UDI
Class IIActive
Port Access Infusion Set PI02Y03
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01N21
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01000
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03021
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH03000
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA01N01
FDA UDI
Class IIUnknown

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