Artimes Balloon Dilatation Catheter 801-1705U

GUDID 06958481412062

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06958481412062
• NIH Device Record Key: 318a024d-af74-44f0-9e4e-b3409eb1ecd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artimes Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 801-1705U
• Company DUNS: 421318800
• Company Name: BrosMed Medical 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958481412062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141025

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-10

On-Brand Devices [Artimes Balloon Dilatation Catheter]

• 06958481412505: rev 01
• 06958481412499: rev 01
• 06958481412482: rev 01
• 06958481412475: rev 01
• 06958481412468: rev 01
• 06958481412451: rev 01
• 06958481412444: rev 01
• 06958481412437: rev 01
• 06958481412420: rev 01
• 06958481412413: rev 01
• 06958481412406: rev 01
• 06958481412390: rev 01
• 06958481412383: rev 01
• 06958481412376: rev 01
• 06958481412369: rev 01
• 06958481412352: rev 01
• 06958481412345: rev 01
• 06958481412338: rev 01
• 06958481412321: rev 01
• 06958481412314: rev 01
• 06958481412307: rev 01
• 06958481412291: rev 01
• 06958481412284: rev 01
• 06958481412277: rev 01
• 06958481412260: rev 01
• 06958481412253: rev 01
• 06958481412246: rev 01
• 06958481412239: rev 01
• 06958481412222: rev 01
• 06958481412215: rev 01
• 06958481412208: rev 01
• 06958481412192: rev 01
• 06958481412185: rev 01
• 06958481412178: rev 01
• 06958481412161: rev 01
• 06958481412154: rev 01
• 06958481412147: rev 01
• 06958481412130: rev 01
• 06958481412123: rev 01
• 06958481412116: rev 01
• 06958481412109: rev 01
• 06958481412093: rev 01
• 06958481412086: rev 01
• 06958481412079: rev 01
• 06958481412062: rev 01
• 06958481412055: rev 01
• 06958481412048: rev 01
• 06958481412031: rev 01
• 06958481412024: rev 01
• 06958481412017: rev 01