Bd Texium Needlefree Syringe K231888 — Device overview

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Proprietary Name

BD Texium™ Needle-Free Syringe

Class 2 (Moderate Risk)

Device Name

Syringe, Piston

Primary Manufacturer

BD SWITZERLAND SARL

Specialty

General Hospital

Device Information

The K Number is a unique identifier assigned by the FDA for tracking medical devices. The Regulation Number references the specific FDA regulation that governs the device, confirming its registration and compliance with FDA standards for easy regulatory verification.

Source
K Number
K231888
Unique FDA identifier
Regulation Number
880.5860
FDA regulation reference

Manufacturer Information

The Manufacturer Information section includes details about the primary manufacturer of the device, including their name and location. If applicable, it also lists the US Agent responsible for representing the manufacturer in the United States. The agent’s contact information, such as email and phone number, is provided for further communication. Additionally, the Registration Addresses section shows where the manufacturer is located worldwide and includes information about their registration status and validity, such as the Expiry Year of their registration and the establishment type (e.g., manufacturing medical devices).

Source
Primary Manufacturer
BD SWITZERLAND SARL
US
US Agent
Authorized U.S. representative for this device
Agent Name
Angela Caravella
Contact
Email:angela.caravella@bd.com
Phone:201-5746985
Agent Address
10020 Pacific Mesa Blve
San Diego, CA 92121

Registration Addresses

2 registered establishments worldwide

Registration Name
BD SWITZERLAND SARL
Expiry year
2026
Registration Number
3012798826
Address
Terre Bonne Park - A4 Route de Crassier 17
Eysins Vaud1262
Establishment Types
Manufacture Medical Device
Registration Name
CAREFUSION
Expiry year
2026
Registration Number
3012410077
Address
10020 Pacific Mesa Blvd
San Diego, CA92121
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility

Owner/Operator Information

The Owner/Operator Information section provides details about the company or entity responsible for the device. It typically includes the company name of the device's owner or operator, as well as the business address, which is the primary location where the business operates or is registered. This information helps identify the entity managing or manufacturing the device and provides transparency regarding the responsible party for regulatory purposes.

Source
Company Name
CareFusion
Device owner/operator
Business Address
10020 Pacific Mesa Blvd San Diego, CA 92121
Primary business location