PORTA PORTA100HF

GUDID 00458237384007

Mobile X-ray system

JOB CORPORATION

Diagnostic x-ray system generator, portable

• Primary Device ID: 00458237384007
• NIH Device Record Key: 98a8333d-0d34-45c0-9d29-93cdd0b4da7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTA
• Version Model Number: 100HF
• Catalog Number: PORTA100HF
• Company DUNS: 695379060
• Company Name: JOB CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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: +81454730113
• Email: info@job-image.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00458237384007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122697

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: 2016-09-21

On-Brand Devices [PORTA]

• 00458237384007: Mobile X-ray system
• 04582373840071: Mobile X-ray system