Definium B2400UDI

GUDID 00195278913814

Definium Tempo Select System UDI

GE Hualun Medical Systems Co., Ltd

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00195278913814
• NIH Device Record Key: d463c840-e36f-426b-9bec-bfb7a2763d14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Definium
• Version Model Number: Tempo Select
• Catalog Number: B2400UDI
• Company DUNS: 554408665
• Company Name: GE Hualun Medical Systems Co., Ltd
• 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: 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	00195278913814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250788

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2025-09-15
• Device Publish Date: 2025-09-05

Devices Manufactured by GE Hualun Medical Systems Co., Ltd

• 00195278913814 - Definium: 2025-09-15Definium Tempo Select System UDI
• 00195278913814 - Definium: 2025-09-15 Definium Tempo Select System UDI
• 00195278901880 - NA: 2025-06-17 Gemini Tube Stand
• 00198953043288 - NA: 2025-04-30 Gemini_Non-tilting_WS
• 00198953043295 - NA: 2025-04-30 Gemini Tilting WS
• 00198953043301 - NA: 2025-04-30 Radiographic Table
• 00198953023259 - NA: 2025-03-10 G4 Non-Tilting Wallstand
• 00198953023266 - NA: 2025-03-10 G3A standard Wallstand