Genus 128-200101

GUDID 26938327904610

1-200 mL Syringe 1-Fill Straw 1-60” Coiled Tubing

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe

• Primary Device ID: 26938327904610
• NIH Device Record Key: e88c92e9-3859-4ce4-91ca-9c76a4dc55b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genus
• Version Model Number: 100104-A
• Catalog Number: 128-200101
• 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: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com
• Phone: 1-866-468-5157
• Email: customerservice@genusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327904616 [Primary]
GS1	26938327904610 [Package]; Contains: 06938327904616; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-21
• Device Publish Date: 2022-01-13

On-Brand Devices [Genus]

• 26938327904672: 1-65 mL & 1-115 ml Syringes 1-Large Spike & 1-Small Spike 1
• 26938327904665: 2-65 mL Syringes 1-Large Spike & 1-Sm
• 26938327904658: 1-200 mL Syringe 1-Large Spike 1-60” Coiled Tubing
• 26938327904641: 1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing
• 26938327904634: 1-60ml Syringes 1-Large Spike
• 26938327904627: 2-200ml Syringes 2-Fill Straws
• 26938327904610: 1-200 mL Syringe 1-Fill Straw 1-60” Coiled Tubing
• 26938327904603: 1-200ml Syringe 1-Fill Straw
• 16938327904682: 21" Transfer Set with C-Clamp and Swabbable Valve
• 26938327904696: 2-60 ml Syringes 1-Large Spike &1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves
• 26938327904719: 2-200ml Syringes 1-Large Spike & 1-Sm
• 26938327904702: 1-200 mL Syringe 1-Large Spike & 1-Fill Straw 1-72" Coiled Tubing
• 26938327904726: 1-125 mL Syringe 1-Large Spike & 1-Fill Straw 1-60" Coiled Tubing
• 16938327904736: 1-21" Transfer Set with Swabbable Valve