VIDEO BRONCHOSCOPE

GUDID 04961333232222

I SERIES HD VIDEO BRONCHOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video bronchoscope, reusable

• Primary Device ID: 04961333232222
• NIH Device Record Key: ad9ac5f4-4887-4421-b8c1-21af64cab8e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDEO BRONCHOSCOPE
• Version Model Number: EB-1990I
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	04961333232222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131028

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

[04961333232222]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-06

On-Brand Devices [VIDEO BRONCHOSCOPE]

• 04961333240081: VIDEO BRONCHOSCOPE (USED)
• 04961333240074: VIDEO BRONCHOSCOPE (USED)
• 04961333232222: I SERIES HD VIDEO BRONCHOSCOPE (REFURBISHED)
• 04961333232215: VIDEO BRONCHOSCOPE (REFURBISHED)
• 04961333232192: VIDEO BRONCHOSCOPE 3.2C 6.2TP 600L (REFURBISHED)
• 04961333232185: VIDEO BRONCHOSCOPE (REFURBISHED)
• 04961333232178: VIDEO BRONCHOSCOPE (REFURBISHED)
• 04961333232161: VIDEO BRONCHOSCOPE (REFURBISHED)
• 04961333232154: VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L (REFURBISHED)