OEC

GUDID 00840682115360

Hangwei GE Medical Systems Co., Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00840682115360
• NIH Device Record Key: 36bc25c7-2cbe-4e8f-8a49-92defcc4f5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEC
• Version Model Number: Brivo Prime
• Company DUNS: 654659689
• Company Name: Hangwei GE 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: 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(414)544-3011
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123603

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-27

On-Brand Devices [OEC]

• 00840682125604: One
• 00840682145541: One CFD
• 00840682118835: Elite MiniView
• 00840682115438: Brivo Essential
• 00840682115377: Brivo Plus
• 00840682115360: Brivo Prime
• 00195278502582: MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView