Site~Rite 8 Ultrasound System 9770603R

GUDID 00801741155383

Site~Rite 8 20mm Cue Linear Probe (Refurbished)

Bard Access Systems, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00801741155383
NIH Device Record Key666c1a3b-8201-4788-bad8-77cc55967034
Commercial Distribution StatusIn Commercial Distribution
Brand NameSite~Rite 8 Ultrasound System
Version Model Number9770603R
Catalog Number9770603R
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 Numbertrue
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741155383 [Primary]

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-28
Device Publish Date2018-11-27

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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