LF 801800B

GUDID 26938327903064

60mL MR Syringe (2) with 90“ Single Check Valve Y-Tubing and Filling Spikes; fits injectors: OptiStar Elite and OptiStar LE

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic syringe

• Primary Device ID: 26938327903064
• NIH Device Record Key: 237ee539-c219-4a8e-b0b4-9fbe631429bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LF
• Version Model Number: 200103-A
• Catalog Number: 801800B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327903060 [Primary]
GS1	26938327903064 [Package]; Contains: 06938327903060; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151960

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-11
• Device Publish Date: 2018-11-09

On-Brand Devices [LF]

• 26938327903224: 90" Y Coiled Tubing with Single Check Valve
• 26938327903217: 60" Y Coiled Tubing with Single Check Valve
• 26938327903200: Handi-Fil Straw
• 26938327903071: 60ml MR Syringe with spike; fits injectors: OptiStar Elite and OptiStar LE
• 26938327903064: 60mL MR Syringe (2) with 90“ Single Check Valve Y-Tubing and Filling Spikes; fits injectors:
• 26938327903057: 150mL Angiographic Syringe with Handi-Fil Straw
• 26938327903040: 200ml Dual CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Handi-Fil Straws
• 26938327903033: 200ml Dual CT Syringe without Check Valve Y Tubing (60"/1500 mm) and Handi-Fil Straws
• 26938327903026: 200ml CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Handi-Fil Straw
• 26938327903019: 200mL CT Syringe with Handi-Fil Straw and Coiled Tube (60"/1500 mm); fits injectors: OptiOne, O
• 26938327903002: 200mL CT Syringe with Handi-Fil Straw
• 26938327903231: 150mL Angiographic Syringe with Large Spike; f
• 26938327903125: 200ml Dual CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Large Spike
• 26938327903118: 200ml Dual CT Syringe without Check Valve Y Tubing (60"/1500 mm) and Large Spikes
• 26938327903101: 200ml CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Large Spike
• 26938327903095: 200mL CT Syringe with Large Spike and Coiled Tube (60"/1500 mm); fits injectors: OptiOne, OptiV
• 26938327903088: 200mL CT Syringe with Large Spike; fits injectors: OptiOne, OptiVantage and CT 9000 ADV
• 16938327906228: 90"(2300mm) Y Coiled Tubing with Single Check Valve
• 16938327906211: 60"(1500mm) Y Tubing with Single Check Valve
• 26938327906201: Handi-Fil Straw
• 26938327906140: 200mL Angiographic Syringe with Filling Spike
• 26938327906133: 150mL Angiographic Syringe with Filling Spike
• 26938327906126: 200ml Dual CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Filling Spike
• 26938327906119: 200ml Dual CT Syringe with Y Tubing (60"/1500 mm) and Fllling Spikes
• 26938327906102: 200ml CT Syringe with Dual Check Valve Y Tubing (60"/1500 mm) and Filling Spike
• 26938327906096: 200mL CT Syringe with Filling Spike and Coiled Tube (60"/1500 mm); fits injectors: OptiOne, Opt
• 26938327906089: 200mL CT Syringe with Filling Spike; fits injectors: OptiOne, OptiVantage and CT 9000 ADV
• 16938327906075: 60ml MR Syringe with spike; fits injectors: OptiStar Elite and OptiStar LE
• 26938327906065: 60mL MR Syringe with Single Check Valve Y-Tubing(90“/2300nn) and Filling Spikes; fits injec
• 26938327906058: 150mL Angiographic Syringe with Handi-Fil Straw
• 26938327906041: 200ml Dual CT Syringe with Dual Check Valves Y Tubing (60"/1500 mm) and Handi-Fil Straws
• 26938327906034: 200ml Dual CT Syringe with Y Tubing (60"/1500 mm) and Handi-Fil Straws
• 26938327906027: 200ml CT Syringe with Dual Check Valves Y Tubing (60"/1500 mm) and Handi-Fil Straw
• 26938327906010: 200mL CT Syringe with Handi-Fil Straw and Coiled Tube (60"/1500 mm); fits injectors: OptiOne, O
• 16938327906259: 90"(2300 mm) Y Coiled Tubing with Dual Check Valve(DEHP FREE)
• 16938327906242: 60"(1500 mm) Coiled Tubing(DEHP FREE)
• 16938327906235: 60"(1500 mm) Y Coiled Tubing with Dual Check Valve(DEHP FREE)