GlideScope® 0570-0419

GUDID 10879123007534

VERATHON INC

Flexible video bronchoscope, single-use

• Primary Device ID: 10879123007534
• NIH Device Record Key: ce0ba2d8-36a9-43ef-be30-ee069f8e626f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlideScope®
• Version Model Number: BFlex™ 2.8
• Catalog Number: 0570-0419
• Company DUNS: 130598584
• Company Name: VERATHON 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	00879123007537 [Primary]
GS1	10879123007534 [Package]; Contains: 00879123007537; 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: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [GlideScope®]

• 10879123006391: BFlex™ 3.8
• 10879123006407: BFlex™ 5.8
• 10879123006339: BFlex™ 5.0
• 10879123007534: BFlex™ 2.8