BladeClear BCS-01

GUDID 00860012804412

BladeClear Small Shaver Accessory

PATHWAY MEDTECH, LLC

Luminal device flushing tubing set, single-use

• Primary Device ID: 00860012804412
• NIH Device Record Key: 91da8c69-c482-4796-b073-caf098966945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BladeClear
• Version Model Number: BCS-01
• Catalog Number: BCS-01
• Company DUNS: 099629934
• Company Name: PATHWAY MEDTECH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012804412 [Primary]

FDA Product Code

• KGZ: Accessories, Catheter

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: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [BladeClear]

• 00860012804412: BladeClear Small Shaver Accessory
• 00860012804405: BladeClear Large Shaver Accessory