Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
Product Description
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. || BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. || The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
B339 is listed on the PDI Alcohol Prep Pads. Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.
Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait
Product Description
PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . || Hook-up kits that contain the affected alcohol prep pads are as follows: || Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; || CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; || Aria, Kit Part number 23189-106, Kit, Aria Hookup; || Aria, Kit Part number 23189-110, Kit, Aria Hookup; || Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; || Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; || LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; || Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; || LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; || 483, Kit Part number 23189-117, Kit, Holter Hookup 483; || Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; || Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; || EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; || EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; || EVO, Kit Part number SK10456, Sample Kit, Disposables. || A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. || The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.
SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.