KUBTEC

GUDID B619X800

Specimen x-ray system

Kubtec

Specimen x-ray system IVD

• Primary Device ID: B619X800
• NIH Device Record Key: cc46cf99-92d0-4123-8641-1211754e769a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KUBTEC
• Version Model Number: XPERT 80
• 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
• Phone: 2033648544
• Email: apangaio@kubtec.com
• Phone: 2033648544
• Email: apangaio@kubtec.com
• Phone: 2033648544
• Email: apangaio@kubtec.com
• Phone: 2033648544
• Email: apangaio@kubtec.com
• Phone: 2033648544
• Email: apangaio@kubtec.com
• Phone: 2033648544
• Email: apangaio@kubtec.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B619X800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071233

FDA Product Code

• MWP: Cabinet,X-Ray System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-22
• 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