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BARD ACCESS SYSTEMS INC

SITE-RITE 8 · General Hospital

510(k): 0 Recall: 0 UDI: 26 MAUDE: 6 Class.: 66

UDI Registrations (26)

Site~Rite 8 Ultrasound System

Site~Rite 8 Software v. 3.0.1

Site~Rite 8 Ultrasound System

SR8 USv2.0.1

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System Console

Site~Rite 8

Site~Rite 8 Ultrasound Application Software

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe

Site~Rite 8

Site~Rite 8 Host System Software

Site Rite 8 Ultrasound System

Site Rite 8 Ultrasound System Application Software

Site Rite 8 Ultrasound System

Site Rite 8 Ultrasound System Host Application Software

Site~Rite 8

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System

Site~Rite 8 Version 2.0.1

Site~Rite 8

Site~Rite 8 Application Host

Site~Rite 8

Site~Rite 8 Ultrasound System Host Software

Site~Rite 8 Ultrasound System

Cue Mounting Arm

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System 32mm Linear Probe (Remanufactured)

Site~Rite 8 Ultrasound System

Site~Rite 8 Software v. 2.3.1

Site~Rite 8 Ultrasound System

Site~Rite 8 20mm Cue Linear Probe

Site~Rite 8

Site~Rite 8 Sherlock Application Software

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System 32mm Linear Probe (Refurbished)

Site~Rite 8

Site~Rite 8 Ultrasound System Software

Site~Rite 8 Ultrasound System

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

Site~Rite 8 Ultrasound System

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

Site~Rite 8

Site~Rite 8 Ultrasound System Application Host Software Version 2.0.2

Site Rite 8 Ultrasound System

Site Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System

Site~Rite 8 Ultrasound System Console (Refurbished)

Site~Rite 8 Ultrasound System

Cue Activator

Site~Rite 8 Ultrasound System

Cue Upgrade Kit (Probe, Activator, Mnt arm)

MAUDE Adverse Events (6)

Malfunction
20231108
Malfunction
20220713
Malfunction
20210322
Malfunction
20200707
Malfunction
20200702
Malfunction

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

General Hospital

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital

Infusion Safety Management Software

General Hospital

Vascular Access Port Kit

General Hospital

Tubing, Fluid Delivery

General Hospital

Basin, Emesis

General Hospital

Oral Administration Set

General Hospital

Ear Irrigation Kit

General Hospital

Nursing Pad, Cohesive Gel

General Hospital

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

General Hospital

Delivery Room Apparel Kit

General Hospital

Support, Scrotal, Therapeutic

General Hospital

Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

General Hospital

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

General Hospital

Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

General Hospital

Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

General Hospital

Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

General Hospital

Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

General Hospital

Water, Vascular Access Flush

General Hospital

Buret Administration Intravenous Kit

General Hospital

Allergen And Vaccine Delivery Needles

General Hospital

Bed, Ac-Powered Adjustable Hospital

General Hospital

Mattress And Bed Deck Cover (Medical Purposes)

General Hospital

Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital