INW Server

GUDID 00840682145756

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 00840682145756
• NIH Device Record Key: d6967847-d5f7-4036-af06-1670fabcc1d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INW Server
• Version Model Number: A1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682145756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130626

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11

On-Brand Devices [INW Server]

• 00840682145756: A1
• 00840682123563: v6.9.6 R3