Site~Rite 8 Ultrasound System SR8v3.0.1

GUDID 00801741225895

Site~Rite 8 Software v. 3.0.1

Bard Access Systems, Inc.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID00801741225895
NIH Device Record Keya5e39e31-368a-40e6-85d0-ccc1f7641655
Commercial Distribution StatusIn Commercial Distribution
Brand NameSite~Rite 8 Ultrasound System
Version Model NumberSR8v3.0.1
Catalog NumberSR8v3.0.1
Company DUNS044611812
Company NameBard Access Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741225895 [Primary]

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-09
Device Publish Date2022-06-01

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

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

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