DeRoyal DRS-DCD201

GUDID 26938327901909

2-200ml Syringes 2-Large Spikes 1- prime tube 1-60" T Coiled Tubing with Dual Check Valves

Shenzhen Boon Medical Supply Co., Ltd.

Angiography kit

• Primary Device ID: 26938327901909
• NIH Device Record Key: 4f815fd7-e6f3-46dd-a82f-537df0635e34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeRoyal
• Version Model Number: 100113-I
• Catalog Number: DRS-DCD201
• 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: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com
• Phone: +1.888.938.7828
• Email: info@deroyal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327901905 [Primary]
GS1	26938327901909 [Package]; Contains: 06938327901905; Package: carton [20 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: 2025-12-08
• Device Publish Date: 2025-11-28

Devices Manufactured by Shenzhen Boon Medical Supply Co., Ltd.

• 26938327901909 - DeRoyal: 2025-12-082-200ml Syringes 2-Large Spikes 1- prime tube 1-60" T Coiled Tubing with Dual Check Valves
• 26938327901909 - DeRoyal: 2025-12-08 2-200ml Syringes 2-Large Spikes 1- prime tube 1-60" T Coiled Tubing with Dual Check Valves
• 26938327909189 - Sinton Medical Products: 2025-11-25 1-200ml Syringe 1-Fill Straw &1-Large Spike 1-72" Coiled Tubing
• 16938327909199 - Sinton Medical Products: 2025-11-25 1-60"(1500mm) Y Tubing with Dual Check Valves
• 16938327909205 - Sinton Medical Products: 2025-11-25 1-72"(1800mm) Y Tubing with Dual Check Valves
• 16938327901704 - SpectraVue: 2025-08-08 1-21'' Transfer Set with Swabable Valve and Ball Check Valve Spike
• 16938327906488 - Guerbet: 2025-08-08 1-21'' Transfer Set with Swabable Valve and Vented Spike
• 16938327909861 - Sinton Medical Products: 2025-08-08 1-21'' Transfer Set with Swabable Valve and Vented Spike
• 16938327909878 - Sinton Medical Products: 2025-08-08 1-21'' Transfer Set with Swabable Valve and Ball Check Valve Spike