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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 2 of 6
DeviceModel / ReferenceRegistriesClassStatus
K-Shield Advantage Port Access Infusion Set PA01N00
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA01N21
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS04021
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y03
FDA UDI
Class IIActive
IV ADMINISTRATION SET with Needleless Access Connector IV-016N
FDA UDI
Class IIUnknown
Port Access Infusion Set PI05001
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y23
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04090
FDA UDI
Class IIUnknown
Iv Administration Set With 22 Micron Filter, Needleless Access Connector IV-025N
FDA UDI
Class IIUnknown
Port Access Infusion Set PI05090
FDA UDI
Class IIUnknown
K-Shield Advantage Small Vein Infusion Set D3KA-25G
FDA UDI
Class IIActive
SB Soft Hood /Undercut type MD-47961
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS03020
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA01N01
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02N01
FDA UDI
Class IIUnknown
Small Vein Infusion Set D3K2-21G
FDA UDI
Class IIUnknown
Port Access Infusion Set PI03000
FDA UDI
Class IIActive
Port Access Infusion Set PI04093
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y21
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA01N91
FDA UDI
Class IIActive
Tentacles NEO MD-27320A
FDA UDI
Class IActive
Winged Collection Set With Multiple Sample Luer Adapter DBM1-23G
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03021
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH03020
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA03020
FDA UDI
Class IIActive
Winged Collection Set With Multiple Sample Luer Adapter DBM1-27G
FDA UDI
Class IIUnknown
Intermittent Injection Site INT-01
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03020
FDA UDI
Class IIActive
Port Access Infusion Set PI01Y21
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03001
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS02N21
FDA UDI
Class IIUnknown
Winged Collection Set With Multiple Sample Luer Adapter DBM1-21G
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04001
FDA UDI
Class IIActive
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH01X21
FDA UDI
Class IIUnknown
K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter PBMA-25G
FDA UDI
Class IIActive
Small Vein Infusion Set D3K1-21G1
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS04001
FDA UDI
Class IIUnknown
Port Access Infusion Set PI05020
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector PS03001
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01Y90
FDA UDI
Class IIActive
K-Shield Advantage Blood Drawing Kit BK-64A
FDA UDI
Class IIActive
K-Shield Advantage Phlebotomy Set With Antineedle Stick Protector BA-16S1
FDA UDI
Class IIUnknown
Small Vein Infusion Set D3K2-22G
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04000
FDA UDI
Class IIActive
K-Shield Advantage Port Access Infusion Set PA03091
FDA UDI
Class IIActive
K-Shield Advantage Winged Blood Collection Set With Pre-Attached Holder DBMH-21G
FDA UDI
Class IIActive
K-Shield Winged Collection Set With Multiple Sample Luer Adapter DBMS-23G
FDA UDI
Class IIUnknown
Port Access Infusion Set PI01021
FDA UDI
Class IIUnknown
K-SHIELD PORT ACCESS INFUSION SET with High Pressure Tubing PH03001
FDA UDI
Class IIUnknown
K-Shield Advantage Port Access Infusion Set PA04020
FDA UDI
Class IIUnknown

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