WHALE

GUDID 06970528550063

Beijing East Whale Imaging Technology Co.,Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 06970528550063
• NIH Device Record Key: 1dcbfd2e-1ff2-4376-80eb-7dc040c50ee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WHALE
• Version Model Number: B6
• Company DUNS: 529847741
• Company Name: Beijing East Whale Imaging Technology 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 Dimensions

• Weight: 150 Kilogram
• Height: 1760 Millimeter
• Width: 670 Millimeter
• Length: 1010 Millimeter
• Weight: 529 Kilogram
• Height: 2476 Millimeter
• Width: 920 Millimeter
• Length: 2820 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970528550063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163429

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: 2017-05-04

On-Brand Devices [WHALE]

• 06970528550063: B6
• 06970528550056: P9
• 06970528550049: P7
• 06970528550032: P5
• 06970528550025: DigiArc 100AU+
• 06970528550018: DigiArc 100AU