Definium

GUDID 00195278070265

Definium Tempo Pro System UDI

Hangwei GE Medical Systems Co., Ltd.

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• Primary Device ID: 00195278070265
• NIH Device Record Key: 36943566-d0ed-4d1b-ab44-c684fbc2ecc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Definium
• Version Model Number: Tempo Pro
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278070265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191699

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

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: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [Definium]

• 00195278118356: Definium Tempo System UDI
• 00195278070265: Definium Tempo Pro System UDI
• 00195278526892: Definium Pace Select system designated medical device