LOGIQ

GUDID 00840682102377

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00840682102377
• NIH Device Record Key: ad8bd0d4-f97c-4eed-9f5d-636e973b03b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOGIQ
• Version Model Number: E9
• Company DUNS: 078863378
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• 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

Customer Support Contacts

• Phone: +1(800)682-5327
• Email: xx@xx.xx

Device Dimensions

• Depth: 830 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152309

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [LOGIQ]

• 00840682138260: E10
• 00840682120173: E9 R3 to R4 UPG
• 00840682120159: E9 R4 to R5 UPG
• 00840682102421: E9 R3 to XDclear 2.0 UPG
• 00840682102414: E9 R5 to XDclear 2.0 UPG
• 00840682102407: E9 R4 to XDclear 2.0 UPG
• 00840682102377: E9
• 00840682145640: E10 R2
• 00195278384041: LOGIQ E10 R3 Console
• 00195278680938: LOGIQ E10 R4 Console