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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 5 of 6
DeviceModel / ReferenceRegistriesClassStatus
Port Access Infusion Set PI01Y91
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03090
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y20
FDA UDI
Class IIActive
Port Access Infusion Set PI01Y01
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA01N91
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03000
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01Y21
FDA UDI
Class IIUnknown
Port Access Infusion Set PI02Y21
FDA UDI
Class IIUnknown
Port Access Infusion Set PI06091
FDA UDI
Class IIUnknown
Small Vein Infusion Set D3K2-24G
FDA UDI
Class IIUnknown
Iv Administration Set With 22 Micron Filter IV-025Y
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01N00
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01Y00
FDA UDI
Class IIUnknown
Winged Collection Set With Multiple Sample Luer Adapter DBM1-24G
FDA UDI
Class IIUnknown
K-Shield Advantage Winged Collection Set With Multiple Sample Luer Adapter DBMA-21G
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH01X91
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02Y90
FDA UDI
Class IIUnknown
Iv Administration Set Secondary Administration Set IV-019
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH03021
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02N20
FDA UDI
Class IIUnknown
SB Soft Hood /Straight type MD-47960
FDA UDI
Class IIActive
Port Access Infusion Set PI03093
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y90
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS04000
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03091
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02Y20
FDA UDI
Class IIUnknown
Port Access Infusion Set PI04023
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04020
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS03021
FDA UDI
Class IIUnknown
SB Knife /Jr type MD-47703W
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03000
FDA UDI
Class IIUnknown
IV ADMINISTRATION SET with Needleless Access Connector IV-017N
FDA UDI
Class IIUnknown
Port Access Infusion Set PI06001
FDA UDI
Class IIUnknown
IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec IV-026N
FDA UDI
Class IIUnknown
Small Vein Infusion Set D3K2-27G
FDA UDI
Class IIUnknown
Port Access Infusion Set PI02Y23
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01N90
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH01X20
FDA UDI
Class IIUnknown
Small Vein Infusion Set D3K1-25G1
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS01Y91
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04021
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04000
FDA UDI
Class IIUnknown
Iv Add-On Filter Administration Set With 22 Micron Filter IV-F02Y
FDA UDI
Class IIActive
K-Shield Advantage Small Vein Infusion Set D3KA-21G
FDA UDI
Class IIActive
Iv Administration Set IV-009Y
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA01N91
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02Y21
FDA UDI
Class IIUnknown
Port Access Infusion Set PI03090
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH01X90
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA01N01
FDA UDI
Class IIActive

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