GUDID 00853704006003

ALLTECH MEDICAL SYSTEMS AMERICA, INC.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00853704006003
• NIH Device Record Key: 1848f175-c2f9-493c-ba63-a16177a5fbe4
• Commercial Distribution Discontinuation: 2017-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: Echostar Comfort
• Company DUNS: 828375696
• Company Name: ALLTECH MEDICAL SYSTEMS AMERICA, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853704006003 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by ALLTECH MEDICAL SYSTEMS AMERICA, INC.

• 00853704006003 - NA: 2018-03-29
• 00853704006003 - NA: 2018-03-29
• 00853704006010 - NA: 2018-03-29