MinXray

GUDID 00861050000316

The MinXray model HF100H+ is a mono-block type high frequency portable x-ray unit. The HF100H+ can be used with conventional diagnostic film or with s

MINXRAY, INC.

Portable basic diagnostic x-ray system, analogue

• Primary Device ID: 00861050000316
• NIH Device Record Key: ed196461-9c1b-4bab-b3ab-69b2be0a9513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MinXray
• Version Model Number: HF100H+
• Company DUNS: 042071001
• Company Name: MINXRAY, 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: true
• 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

Customer Support Contacts

• Phone: 1-847-564-0323
• Email: info@minxray.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861050000316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052721

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

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