InfiMed Platinum One, DSA, CCD Camera

GUDID 00858086006108

INFIMED, INC.

X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00858086006108
• NIH Device Record Key: 9f3fca8b-191f-4256-8ce6-09912e2d9032
• Commercial Distribution Discontinuation: 2017-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: InfiMed Platinum One, DSA, CCD Camera
• Version Model Number: PlatinumOne DSA
• Company DUNS: 197117211
• Company Name: INFIMED, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858086006108 [Primary]

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

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: 2019-12-09
• Device Publish Date: 2016-09-16

Devices Manufactured by INFIMED, INC.

• 00858086006009 - InfiMed i5, DSA, CCD Camera: 2019-12-09
• 00858086006016 - InfiMed i5, DR, Digital Receptor: 2019-12-09
• 00858086006023 - InfiMed Nexus, RF/DR, Non Varian Digital Receptor: 2019-12-09
• 00858086006030 - InfiMed Nexus, RF/DR, Digital Receptor: 2019-12-09
• 00858086006047 - InfiMed Platinum One, RF, CCD Camera: 2019-12-09
• 00858086006054 - InfiMed i5, RF, CCD Camera: 2019-12-09
• 00858086006061 - InfiMed Precision RXi, RF/DSA, CCD Camera: 2019-12-09
• 00858086006078 - InfiMed Precision MPi, RF, CCD Camera: 2019-12-09