Guerbet 241828

GUDID 26938327906911

24h CT 200ml Syringe(Orange)

Shenzhen Boon Medical Supply Co., Ltd.

Contrast medium injection system syringe

• Primary Device ID: 26938327906911
• NIH Device Record Key: 640c87b0-9fde-4ae1-8c9c-6aaf4d27f7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guerbet
• Version Model Number: 372401
• Catalog Number: 241828
• Company DUNS: 529174252
• Company Name: Shenzhen Boon Medical Supply Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com
• Phone: 9999999999
• Email: client.complaint@guerbet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327906917 [Primary]
GS1	26938327906911 [Package]; Contains: 06938327906917; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241109

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27

On-Brand Devices [Guerbet]

• 26938327906164: OPTIV SU 1XSYR200ML Y-COIL150CM 2V J X50 Optivantage® CT Syringe with Dual Check Valve Y tubing
• 26938327906157: OPTIV SU/OPO 1XSYR200ML COIL150CM J X50 Optivantage® / OptiOne® CT Syringe with Handi-Fil stra
• 26938327906300: OPTIV SU 2XSYR200ML Y-COIL150CM 2V S X20 Optivantage® Dual CT Syringe with Dual Check Valve Y
• 26938327906294: OPTIV SU 2XSYR200ML Y-COIL150CM OV S X20 Optivantage® Dual CT Syringe with Y tubing (60"/1500m
• 26938327906287: OPTIV SU 1XSYR200ML Y-COIL150CM 2V S X50 Optivantage® CT Syringe with Dual Check Valve Y tubin
• 26938327906270: OPTIV SU/OPO 1XSYR200ML COIL150CM S X50 Optivantage®/ OptiOne® CT Syringe with Coiled Tube(60"
• 26938327906195: OPTIS SU 2XSYR60ML Y-COIL150CM S X50 Optistar Elite®Dual MR syringe with Single Check Valve Y
• 26938327906188: OPTIV SU 2XSYR200ML Y-COIL150CM 2V J X20 Optivantage®Dual CT Syringe with Dual Check Valve Y tu
• 26938327906171: OPTIV SU 2XSYR200ML Y-COIL150CM OV J X20 Optivantage ® Dual CT Syringe with Y tubing (60"/1500m
• 16938327906341: 1-21'' Transfer Set with Swabable Valve and Vented Spike
• 26938327906935: 24h CT 200/200ml Syringes(Orange)
• 26938327906928: 12h CT 200/200ml Syringes(Green)
• 26938327906911: 24h CT 200ml Syringe(Orange)
• 26938327906904: 12h CT 200ml Syringe(Green)
• 16938327906488: 1-21'' Transfer Set with Swabable Valve and Vented Spike