Parafleet SC 035 PTA Balloon Dilatation Catheter F35-060300-200

GUDID 06942265520838

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06942265520838
• NIH Device Record Key: 9af4ae87-ef15-47f1-8970-fa32ecce1687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parafleet SC 035 PTA Balloon Dilatation Catheter
• Version Model Number: rev 02
• Catalog Number: F35-060300-200
• 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	06942265520838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243704

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [Parafleet SC 035 PTA Balloon Dilatation Catheter]

• 06942265520951: rev 02
• 06942265520944: rev 02
• 06942265520937: rev 02
• 06942265520920: rev 02
• 06942265520913: rev 02
• 06942265520906: rev 02
• 06942265520890: rev 02
• 06942265520883: rev 02
• 06942265520876: rev 02
• 06942265520869: rev 02
• 06942265520845: rev 02
• 06942265520838: rev 02
• 06942265520821: rev 02
• 06942265520814: rev 02
• 06942265520791: rev 02
• 06942265520784: rev 02
• 06942265520777: rev 02
• 06942265520760: rev 02
• 06942265520753: rev 02
• 06942265520746: rev 02
• 06942265520739: rev 02
• 06942265520722: rev 02
• 06942265520715: rev 02
• 06942265520708: rev 02
• 06942265520692: rev 02
• 06942265520685: rev 02
• 06942265520678: rev 02