Adult loader

GUDID 03700620600495

Telescopic stent loader for tracheal tube, color coded yellow

EFER ENDOSCOPY

Rigid bronchoscope

• Primary Device ID: 03700620600495
• NIH Device Record Key: 91c58acf-d128-4d04-b34d-76e7c36eece2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult loader
• Version Model Number: BI2200-3
• Company DUNS: 286097451
• Company Name: EFER ENDOSCOPY
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	03700620600495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854414

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

[03700620600495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-15
• Device Publish Date: 2023-11-07

On-Brand Devices [Adult loader]

• 03700620600518: Telescopic stent loader, color coded black
• 03700620600525: Double action stent loader, color coded yellow/orange
• 03700620600501: Telescopic stent loader, color coded red
• 03700620600495: Telescopic stent loader for tracheal tube, color coded yellow