Smart Check Cushion Monitoring Device

GUDID 00613732090289

Roho, Inc.

Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor Wheelchair occupant position sensor

• Primary Device ID: 00613732090289
• NIH Device Record Key: 52f58b97-c53f-4c9f-b103-b0f41d3822a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Check Cushion Monitoring Device
• Version Model Number: SMARTCHK01-DEMO
• Company DUNS: 006614792
• Company Name: Roho, 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: true
• 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 Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613732090289 [Primary]

FDA Product Code

• JFC: System, Pressure Measurement, Intermittent

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: 2022-12-05
• Device Publish Date: 2022-11-25

On-Brand Devices [Smart Check Cushion Monitoring Device ]

• 00613732090289: SMARTCHK01-DEMO
• 00613732087746: SMARTCHECK-01