SEER

GUDID 00840682116879

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 00840682116879
• NIH Device Record Key: 7678a6ac-1b8b-422d-9b9c-8481127712e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEER
• Version Model Number: 1000 IOS Application
• 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	00840682116879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130785

FDA Product Code

• MWJ: ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

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: 2019-11-08
• Device Publish Date: 2016-06-09

On-Brand Devices [SEER]

• 00840682116886: 1000 PC Application
• 00840682116879: 1000 IOS Application
• 00840682108232: 1000
• 00840682108201: 12