KUBTEC

GUDID B619X200

specimen x-ray system

Kubtec

Specimen x-ray system IVD Specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD

• Primary Device ID: B619X200
• NIH Device Record Key: 60feec4a-8d79-4a6f-a9c0-d88878fab685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KUBTEC
• Version Model Number: XPERT 20
• 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	B619X200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083510

FDA Product Code

• KPR: System, X-Ray, Stationary

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