BroncTru™ Transbronchial Access Tool

GUDID 00856571007975

BRONCUS MEDICAL INC.

Bronchoscopic catheter

• Primary Device ID: 00856571007975
• NIH Device Record Key: d749ea02-1eac-458e-8c20-9c897c17a35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BroncTru™ Transbronchial Access Tool
• Version Model Number: AK-46-00
• Company DUNS: 078684808
• Company Name: BRONCUS MEDICAL INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007975 [Primary]
GS1	10856571007972 [Package]; Package: Shipping Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232601

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

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: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [BroncTru™ Transbronchial Access Tool]

• 00856571007982: AK-91-00
• 00856571007975: AK-46-00
• 00856571007968: AK-64-00
• 00856571007951: AK-82-00
• 00856571007944: AK-91-55
• 00856571007937: AK-46-55
• 00856571007920: AK-64-60
• 00856571007913: AK-82-70