Site~Rite 8 Ultrasound System SR8 USv2.0.1

GUDID 00801741161070

SR8 USv2.0.1

Bard Access Systems, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00801741161070
• NIH Device Record Key: c3c66a80-0573-48f9-85b1-7bfdbf808366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Site~Rite 8 Ultrasound System
• Version Model Number: SR8 USv2.0.1
• Catalog Number: SR8 USv2.0.1
• 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: 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

Customer Support Contacts

• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741161070 [Primary]

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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