Discovery

GUDID 00840682120975

GE MEDICAL SYSTEMS, INC.

PET system

• Primary Device ID: 00840682120975
• NIH Device Record Key: 5b369760-97b1-464d-bb85-d7a7800ffd7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: MI Digital Ready
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, 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	00840682120975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133657

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2016-10-11

On-Brand Devices [Discovery]

• 00840682146166: MI Digital Ready
• 00840682143523: MI
• 00840682136709: XR656 HD Upgrade
• 00840682125703: IQ 2.0
• 00840682120975: MI Digital Ready
• 00840682108218: MI
• 00840682103107: IQ
• 00840682103053: PETCT 610
• 00840682102995: PETCT 710
• 00195278098603: PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make
• 00195278840226: XR656HD UDI Label