Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector	PS04090	FDA UDI	Class II	Unknown
K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector	PS02Y01	FDA UDI	Class II	Unknown
Port Access Infusion Set	PI01090	FDA UDI	Class II	Unknown
K-Shield Advantage Port Access Infusion Set	PA01N20	FDA UDI	Class II	Active
Port Access Infusion Set	PI03090	FDA UDI	Class II	Active
K-Shield Advantage Port Access Infusion Set	PA01N00	FDA UDI	Class II	Unknown
Port Access Infusion Set	PI04001	FDA UDI	Class II	Active
Port Access Infusion Set	PI02Y93	FDA UDI	Class II	Unknown
Small Vein Infusion Set	D3K2-20G	FDA UDI	Class II	Unknown
K-SHIELD Zen Winged Blood Collection Set	PBM-23G	FDA UDI	Class II	Active
Port Access Infusion Set	PI03003	FDA UDI	Class II	Unknown
K-Shield Advantage Winged Blood Collection Set With Pre-Attached Holder	DBMH-25G	FDA UDI	Class II	Active
Small Vein Infusion Set	D3K2-23G	FDA UDI	Class II	Unknown
K-Shield Advantage Small Vein Infusion Set	D3KA-21G	FDA UDI	Class II	Active
Port Access Infusion Set	PI01091	FDA UDI	Class II	Unknown
Port Access Infusion Set	PI04000	FDA UDI	Class II	Active
K-Shield Winged Collection Set With Multiple Sample Luer Adapter	DBMS-21G	FDA UDI	Class II	Unknown
K-Shield Winged Collection Set With Multiple Sample Luer Adapter	DBMS-25G	FDA UDI	Class II	Unknown
Intermittent Injection Site	INT-01	FDA UDI	Class II	Active
Small Vein Infusion Set	D3K1-23G1	FDA UDI	Class II	Unknown
Small Vein Infusion Set	D3K2-25G	FDA UDI	Class II	Unknown
Winged Collection Set With Multiple Sample Luer Adapter	DBM1-19G	FDA UDI	Class II	Unknown
IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec	IV-018N	FDA UDI	Class II	Unknown
K-Shield Advantage Winged Collection Set With Multiple Sample Luer Adapter	DBMA-25G	FDA UDI	Class II	Active
Rapid Transfer Kawasumi Multiple Sample Adapter with Pre-Attached Holder	MBCH-02	FDA UDI	Class II	Active

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