Genus 128-400101

GUDID 26938327904641

1-200 mL Syringe 1- fill straw 1-60” Coiled Tubing

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic catheter, single-use

• Primary Device ID: 26938327904641
• NIH Device Record Key: d36af09f-4cc9-4443-b0a5-4b4913c8638c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genus
• Version Model Number: 100111-A
• Catalog Number: 128-400101
• 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	06938327904647 [Primary]
GS1	26938327904641 [Package]; Contains: 06938327904647; 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
• 26938327904740: 2-100ml Syringes 1-Large Spike & 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves
• 26938327904764: 2-200ml Syringes 2-Large Spikes 1-72"
• 26938327904757: 1-200 ml Syringe 1- Large Spike 1-72" Coiled Tubing with check valve 1- prime tube