DRSHD 1080p

GUDID 00817613020383

DRSHD 1080p System, Rev 7

MED X CHANGE, INC.

Endoscopic video image processing unit

• Primary Device ID: 00817613020383
• NIH Device Record Key: bfb3f496-d998-4385-8a07-b218b24e2a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRSHD 1080p
• Version Model Number: DRSHD.7
• Company DUNS: 051244569
• Company Name: MED X CHANGE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817613020383 [Primary]

FDA Product Code

• LMB: Device, Digital Image Storage, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-05-30

On-Brand Devices [DRSHD 1080p]

• 00817613020383: DRSHD 1080p System, Rev 7
• 00817613020147: Accessory Pack for DRSHD Rev. 7
• 00817613020000: DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#