BFlex™ 0570-0434

GUDID 10879123008548

BFlex™ 2 Ultraslim 2.8 Single-Use Bronchoscope

Verathon Medical (Canada) ULC

Flexible video bronchoscope, single-use

• Primary Device ID: 10879123008548
• NIH Device Record Key: ae235517-68bb-4685-984d-34d4624ab717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BFlex™
• Version Model Number: BFlex™ 2 Ultraslim 2.8
• Catalog Number: 0570-0434
• Company DUNS: 243738320
• Company Name: Verathon Medical (Canada) ULC
• 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: true
• 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	00879123008541 [Primary]
GS1	10879123008548 [Package]; Contains: 00879123008541; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211947

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: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [BFlex™]

• 10879123008579: BFlex™ 2 Large 5.8 Single-Use Bronchoscope
• 10879123008562: BFlex™ 2 Regular 5.0 Single-Use Bronchoscope
• 10879123008555: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
• 10879123008548: BFlex™ 2 Ultraslim 2.8 Single-Use Bronchoscope