Site~Rite 8 Ultrasound System 9770606

GUDID 00801741155390

Cue Start Kit (SR8, Probe, Activator, Mnt arm)

Bard Access Systems, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00801741155390
• NIH Device Record Key: e9300692-3dc4-413e-a457-dcd8d923ccb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Site~Rite 8 Ultrasound System
• Version Model Number: 9770606
• Catalog Number: 9770606
• Company DUNS: 044611812
• Company Name: Bard Access Systems, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741155390 [Primary]

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2018-12-28
• Device Publish Date: 2018-11-27

On-Brand Devices [Site~Rite 8 Ultrasound System]

• 00801741161070: SR8 USv2.0.1
• 00801741155406: Cue Upgrade Kit (Probe, Activator, Mnt arm)
• 00801741155390: Cue Start Kit (SR8, Probe, Activator, Mnt arm)
• 00801741155383: Site~Rite 8 20mm Cue Linear Probe (Refurbished)
• 00801741143809: Site~Rite 8 Version 2.0.1
• 00801741138324: Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe
• 00801741138317: Site~Rite 8 Ultrasound System 32mm Linear Probe (Remanufactured)
• 00801741138300: Site~Rite 8 Ultrasound System 32mm Linear Probe (Refurbished)
• 00801741138294: Site~Rite 8 Ultrasound System 32mm Linear Probe
• 00801741138287: Site~Rite 8 Ultrasound System Console (Remanufactured)
• 00801741138270: Site~Rite 8 Ultrasound System Console (Refurbished)
• 00801741138263: Site~Rite 8 Ultrasound System Console
• 00801741138256: Cue Mounting Arm
• 00801741138232: Cue Activator
• 00801741138218: Site~Rite 8 20mm Cue Linear Probe
• 00801741138201: Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe (Remanufactured)
• 00801741138195: Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe (Refurbished)
• 00801741225895: Site~Rite 8 Software v. 3.0.1
• 00801741219382: Site~Rite 8 Software v. 2.3.1