Parafleet SC 018 PTA Balloon Dilatation Catheter F35-030080-120

GUDID 06942265518309

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06942265518309
• NIH Device Record Key: be44bd0a-91b2-4315-8858-3f3f9fcdddff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parafleet SC 018 PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: F35-030080-120
• 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	06942265518309 [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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [Parafleet SC 018 PTA Balloon Dilatation Catheter]

• 06942265515940: rev 01
• 06942265515933: rev 01
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• 06942265516275: rev 01
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• 06942265516084: rev 01
• 06942265516077: rev 01
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• 06942265516053: rev 01
• 06942265516046: rev 01
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• 06942265508461: rev 01
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• 06942265508331: rev 01