OEC

GUDID 00840682118835

Hangwei GE Medical Systems Co., Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00840682118835
• NIH Device Record Key: 0b374c29-9029-479a-9937-5d21a33edaf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEC
• Version Model Number: Elite MiniView
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160131

FDA Product Code

• OXO: Image-intensified fluoroscopic x-ray system, mobile

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: 2016-08-26

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
• 00195278685001: MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD