BOON

GUDID 06938327900595

1-200 mL Syringe 1-Large Spike 1-72” Coiled Tubing

Shenzhen Boon Medical Supply Co., Ltd.

Angiographic catheter, single-use

• Primary Device ID: 06938327900595
• NIH Device Record Key: d84baf2e-5da6-489c-a36b-1a2c6f3878ac
• Commercial Distribution Discontinuation: 2020-04-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BOON
• Version Model Number: 100103-B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938327900595 [Primary]
GS1	26938327900595 [Package]; Package: Carton [50 Units]; In Commercial Distribution
GS1	26938327900599 [Package]; Package: Carton [50 Units]; Discontinued: 2020-04-26; Not 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: 7
• Public Version Date: 2020-04-27
• Device Publish Date: 2017-09-11

On-Brand Devices [BOON]

• 06938327900618: 1-100ml Syringe 1-Large Spike
• 06938327900595: 1-200 mL Syringe 1-Large Spike 1-72” Coiled Tubing
• 06938327900465: 2-200 mL Syringes 2-Large Spikes 1-72""
• 06938327900458: 2-200 mL Syringes 2-Fill Straws 1-72"
• 06938327900236: 1200mm 1200PSI High Pressure Braided Line with Rotating Luer
• 06938327900229: 1000mm 1200PSI High Pressure Braided Line with Rotating Luer
• 06938327900212: 750mm High Pressure Braided Line with Rotating Luer
• 06938327900205: 500mm 1200PSI High Pressure Braided Line with Rotating Luer
• 06938327900069: 1-130ml Syringe 1-Fill Straw
• 06938327900021: 2-200 mL Syringes 2-Fill Straws & 2 Large Spikes 1-72"" Y Coiled Tubing with Dual Check
• 06938327900014: 1-200 mL Syringe 1-Fill Straw 1-72” Coiled Tubing