Parafleet SC 014 PTA Balloon Dilatation Catheter F14-040100-090

GUDID 06942265502094

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06942265502094
• NIH Device Record Key: 3d5487f6-b460-4a2b-9784-fe673305ce90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parafleet SC 014 PTA Balloon Dilatation Catheter
• Version Model Number: rev 02
• Catalog Number: F14-040100-090
• 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	06942265502094 [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: 2025-05-19
• Device Publish Date: 2025-05-09

On-Brand Devices [Parafleet SC 014 PTA Balloon Dilatation Catheter]

• 06942265500212: rev 02
• 06942265500205: rev 02
• 06942265500199: rev 02
• 06942265500175: rev 02
• 06942265500168: rev 02
• 06942265500151: rev 02
• 06942265500144: rev 02
• 06942265500137: rev 02
• 06942265500120: rev 02
• 06942265500113: rev 02
• 06942265500106: rev 02
• 06942265500090: rev 02
• 06942265500083: rev 02
• 06942265500076: rev 02
• 06942265500069: rev 02
• 06942265502001: rev 02
• 06942265501998: rev 02
• 06942265501981: rev 02
• 06942265501974: rev 02
• 06942265501967: rev 02
• 06942265501950: rev 02
• 06942265501943: rev 02
• 06942265501936: rev 02
• 06942265501929: rev 02
• 06942265501912: rev 02
• 06942265501905: rev 02
• 06942265501899: rev 02
• 06942265501868: rev 02
• 06942265501851: rev 02
• 06942265501844: rev 02
• 06942265501837: rev 02
• 06942265501745: rev 02
• 06942265501738: rev 02
• 06942265501721: rev 02
• 06942265501707: rev 02
• 06942265501684: rev 02
• 06942265501677: rev 02
• 06942265501660: rev 02
• 06942265501639: rev 02
• 06942265501615: rev 02
• 06942265501455: rev 02
• 06942265501448: rev 02
• 06942265501431: rev 02
• 06942265501424: rev 02
• 06942265501417: rev 02
• 06942265501400: rev 02
• 06942265501394: rev 02
• 06942265501387: rev 02
• 06942265501370: rev 02
• 06942265501363: rev 02