MUSE

GUDID 00840682100182

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiology information system application software

• Primary Device ID: 00840682100182
• NIH Device Record Key: e83a01c0-222c-475d-846f-3d2b97d6e6f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUSE
• Version Model Number: v9
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)558-7044
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110132

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-04
• Device Publish Date: 2016-06-20

On-Brand Devices [MUSE]

• 00840682142809: NX
• 00840682100182: v9
• 00195278458070: MUSE NX R2 SOFTWARE