CommandEP

GUDID 00850013331031

HMD

Sentiar, Inc.

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• Primary Device ID: 00850013331031
• NIH Device Record Key: 905cca78-92b7-4a45-b319-31ba64fa94de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CommandEP
• Version Model Number: HMD01
• Company DUNS: 080306326
• Company Name: Sentiar, Inc.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 105 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013331031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192890

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-10-26
• Device Publish Date: 2020-10-16

On-Brand Devices [CommandEP]

• 00850013331031: HMD
• 00850013331024: Enclosure
• 00850013331017: Data Manager PC
• 00850013331048: HMD
• 00850013331000: Data Manager PC
• 00850013331079: HMD Custom Lens Insert