WHALE

GUDID 06970528550018

Beijing East Whale Imaging Technology Co.,Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 06970528550018
• NIH Device Record Key: 2e97bae1-c486-4bcd-9120-a680a1eac98c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WHALE
• Version Model Number: DigiArc 100AU
• 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: 600 Kilogram
• Width: 922 Millimeter
• Length: 2234 Millimeter
• Height: 2540 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970528550018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151280

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: 2016-09-04

On-Brand Devices [WHALE]

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