KUBTEC

GUDID B619KUB2500

mobile x-ray system

Kubtec

Mobile basic diagnostic x-ray system, digital

• Primary Device ID: B619KUB2500
• NIH Device Record Key: f7cb9adf-b70c-4176-bc2e-0bdfedae64ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KUBTEC
• Version Model Number: KUB250
• Company DUNS: 361955128
• Company Name: Kubtec
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 2033648544
• Email: apangaio@kubtec.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B619KUB2500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141539

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-17
• Device Publish Date: 2017-12-22

On-Brand Devices [KUBTEC]

• B619X80L0: Specimen x-ray system
• B619X800: Specimen x-ray system
• B619X420: Specimen x-ray system
• B619X400: Specimen x-ray system
• B619X200: specimen x-ray system
• B619KUB2500: mobile x-ray system