Guerbet

Basic Information

• Brand Name: Guerbet
• Primary DI: 06938327906177
• Version / Model: 100114-CF
• Catalog Number: 247240
• Company Name: Shenzhen Boon Medical Supply Co., Ltd.
• Labeler DUNS: 529174252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-17
• Public Version: 2
• Public Version Date: 2025-06-24
• Public Version Status: Update
• Public Device Record Key: d802dbc4-0ba9-4314-ad79-9388c8c1708b
• Distribution End Date: 9999-12-31

Device Description

OPTIV SU 2XSYR200ML Y-COIL150CM OV J X20 Optivantage ® Dual CT Syringe with Y tubing (60"/1500mm)and Handi-Fil Straws - 200mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26938327906171	GS1	carton	20	In Commercial Distribution	9999-12-31
Primary	06938327906177	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]