OEC

GUDID 00195278685001

MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD

Hangwei GE Medical Systems Co., Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00195278685001
• NIH Device Record Key: 498830b2-c14b-4b0f-80ef-1829a5f8fcdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEC
• Version Model Number: One ASD
• 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: true
• 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	00195278685001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240828

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

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