SLT IVUS P1 Pulser Receiver Unit PRU001

GUDID 00850045446000

See LBL-0998, SLT IVUS P1 System Manual

Provisio Medical, Inc.

Cardiovascular ultrasound imaging system

• Primary Device ID: 00850045446000
• NIH Device Record Key: 70847578-ac77-4ac3-9d7b-2ef016bc48b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLT IVUS P1 Pulser Receiver Unit
• Version Model Number: PRU001
• Catalog Number: PRU001
• Company DUNS: 015877254
• Company Name: Provisio Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com
• Phone: 858-524-3901
• Email: info@provisiomedical.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045446000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233948

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2024-06-03
• Device Publish Date: 2024-05-24

Devices Manufactured by Provisio Medical, Inc.

• 00850045446000 - SLT IVUS P1 Pulser Receiver Unit: 2024-06-03See LBL-0998, SLT IVUS P1 System Manual
• 00850045446000 - SLT IVUS P1 Pulser Receiver Unit: 2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
• 00850045446024 - SLT IVUS Support Crossing Catheter: 2024-06-03 The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transduce
• 00850045446031 - SLT IVUS P1 Display Unit: 2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
• 00850045446048 - SLT IVUS P1 Cart: 2024-06-03 See LBL-0998, SLT IVUS P1 System Manual