SiteRite 9770816

GUDID 00801741234347

BD SiteRite 9 Ultrasound System Probe Holder

Bard Access Systems, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00801741234347
• NIH Device Record Key: 3c825106-67e8-4966-82b9-8bcf3c223908
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SiteRite
• Version Model Number: 9770816
• Catalog Number: 9770816
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• 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 Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741234347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231283

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: 2025-05-21
• Device Publish Date: 2025-05-13

On-Brand Devices [SiteRite]

• 00801741234347: BD SiteRite 9 Ultrasound System Probe Holder
• 00801741227738: BD SiteRite 9 Cue Linear Probe Refurbished