Lunar iDXA

GUDID 00840682117029

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: 00840682117029
• NIH Device Record Key: 02960696-3f38-4059-8b5e-3583ac8b3e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lunar iDXA
• Version Model Number: F1
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052581

FDA Product Code

• KGI: Densitometer, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-28
• Device Publish Date: 2016-06-27

Devices Manufactured by GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

• 00195278687777 - Venue Go: 2024-07-18 Venue Go R5 MD
• 00195278703200 - Venue: 2024-07-18 Venue R5 final Assembly
• 00195278703224 - Venue Fit: 2024-07-18 Venue Fit R5 Final Assembly
• 00195278703453 - Venue Go: 2024-07-18 Venue Go R5 Final Assembly
• 00195278703477 - Venue: 2024-07-18 Venue R5 MD
• 00195278703484 - Venue Fit: 2024-07-18 Venue Fit R5 MD
• 00195278754011 - Venue Sprint: 2024-07-18 Venue Sprint R5 MD
• 00195278680938 - LOGIQ: 2023-12-12 LOGIQ E10 R4 Console