Medical Imaging Solutions International 100302

GUDID 26938327901046

1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic syringe

• Primary Device ID: 26938327901046
• NIH Device Record Key: 811dc442-f3c0-4124-bd90-54d34b0cc80e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Imaging Solutions International
• Version Model Number: 200102-A
• Catalog Number: 100302
• 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: 1-800-603-6501
• Email: orders@misisyringes.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327901042 [Primary]
GS1	26938327901046 [Package]; Contains: 06938327901042; 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: 3
• Public Version Date: 2020-04-03
• Device Publish Date: 2018-08-14

On-Brand Devices [Medical Imaging Solutions International]

• 26938327901312: 1-J tube
• 26938327901305: 1-Large Spike
• 26938327901176: 2-200ml Syringes 2-Large Spikes
• 26938327901169: 1-200 mL Syringe 1- Large Spike 1-60” Coiled Tubing"
• 26938327901152: 2-200ml Syringes 2-fill straws
• 26938327901145: 1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing"
• 26938327901138: 1-60ml Syringes 1-Large Spike
• 26938327901121: 2-60ml Syringes 1-Large Spike & 1-Small Spi
• 26938327901114: 1-150ml Syringe 1-Fill Straw
• 26938327901107: 2-200ml Syringes 2-Large Spikes
• 26938327901091: 1-200 mL Syringe 1-Large Spike 1-60” Coiled Tubing
• 26938327901084: 2-200ml Syringes 2-Fill Straws
• 26938327901077: 1-200 mL Syringe 1-Fill Straw 1-60” Y Coiled Tubing with Dual Check Valves
• 26938327901060: 1-200 mL Syringe 1-Fill Straw 1-60” Coiled Tubing
• 26938327901053: 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" T Coiled Tubing with Check Valve
• 26938327901046: 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-
• 26938327901039: 2-65 mL Syringes 1-Large Spike, 1-Smal
• 26938327901022: 2-65 mL Syringes 1-Large Spike, 1-Sma
• 26938327901015: 1-150ml Syringe 1-Fill Straw
• 26938327901008: 1-200ml Syringe 1-Fill Straw
• 06938327900588: 1-60ml Syringes 1-Large Spike
• 26938327900558: 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-
• 06938327900533: 2-65 mL Syringes 1-Large Spike & 1-Small Spike 1-96" T Coil
• 06938327900502: 2-200ml Syringes 2-Large Spikes
• 06938327900496: 2-200ml Syringes 2-fill straws
• 06938327900489: 2-200ml Syringes 2-Large Spikes
• 06938327900472: 2-200ml Syringes 2-Fill Straws
• 06938327900434: 1-200 mL Syringe 1- Large Spike 1-60” Coiled Tubing"
• 06938327900427: 1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing"
• 06938327900410: 1-200 mL Syringe 1-Fill Straw 1-60” Y Coiled Tubing with Dual Check Valves
• 06938327900403: 1-200 mL Syringe 1-Large Spike 1-60” Coiled Tubing"
• 26938327900268: J tube
• 26938327900244: Large Spike
• 26938327900107: 1-150ml Syringe 1-Fill Straw
• 06938327900090: 2-60ml Syringes 1-Large Spike & 1-Small Sp
• 06938327900076: 1-200 mL Syringe 1-Fill Straw 1-60” Coiled Tubing
• 26938327900053: 1-150ml Syringe 1-Fill Straw
• 06938327900045: 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-
• 06938327900038: 2-65 mL Syringes 1-Large Spike, 1-Sma
• 26938327900008: 1-200ml Syringe 1-Fill Straw
• 26938327900988: 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-
• 26938327900957: Large Spike
• 16938327901339: 1-60"(1500mm) Coiled Tubing
• 16938327901322: 1-72"(1800mm) Y Coiled Tubing with Dual Check Valves