BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack Number CDS981740G ; 21) VP SHUNT CDS, Pack Number CDS981740I ; 22) PORT A CATH , Pack Number CDS982047Q ; 23) SHY VP SHUNT CDS, Pack Number CDS982389J; 24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ; 25) A-V FISTULA , Pack Number CDS982637K ; 26) A-V FISTULA , Pack Number CDS982637L ; 27) VASCULAR TRAUMA , Pack Number CDS982641K ; 28) AV FISTULA CDS, Pack Number CDS982660G ; 29) AV FISTULA CDS, Pack Number CDS982660I ; 30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ; 31) AV FISTULA/ACCESS , Pack Number CDS983060I ; 32) AV FISTULA/ACCESS , Pack Number CDS983060J ; 33) AV SHUNT CDS, Pack Number CDS983098B ; 34) AV SHUNT CDS, Pack Number CDS983098C ; 35) VASCULAR ACCESS CDS , Pack Number CDS983105C ; 36) VP SHUNT, Pack Number CDS983366K ; 37) VP SHUNT, Pack Number CDS983366L ; 38) AV FISTULA, Pack Number CDS983638G ; 39) AV FISTULA, Pack Number CDS983638I ; 40) AV FISTULA, Pack Number CDS983638J ; 41) BARIATRIC CDS , Pack Number CDS983657J ; 42) BARIATRIC CDS , Pack Number CDS983657K ; 43) BARIATRIC CDS , Pack Number CDS983883C ; 44) GROTH AV FISTULA CDS, Pack Number CDS984191P ; 45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ; 46) GROTH AV FISTULA CDS, Pack Number CDS984191S ; 47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ; 48) GROTH LASER VEIN, Pack Number CDS984193R; 49) SHY AV FISTULA CDS, Pack Number CDS984512G ; 50) AV FISTULA, Pack Number CDS985510G ; 51) THORACOSTOMY TRAY , Pack Number CHT2010; 52) TRAUMA CHEST TUBE SET , Pack Number CHT2015; 53) BARD MYPICC$ KIT, Pack Number CK000234A; 54) BARD MYPICC$ KIT, Pack Number CK000236A; 55) BARD MYPICC$ KIT, Pack Number CK000324 ; 56) BARD MYPICC$ KIT, Pack Number CK000325 ; 57) BARD MYPICC$ KIT, Pack Number CK000645A; 58) BARD MYPICC$ KIT, Pack Number CK000646A; 59) BARD MYPICC$ KIT, Pack Number CK000647A; 60) BARD MYPICC$ KIT, Pack Number CK000713 ; 61) BARD MYPICC$ KIT, Pack Number CK000714 ; 62) CENTRAL LINE TRAY , Pack Number CVI4705; 63) CVC INSERTION PACK, Pack Number CVI4720; 64) ****, Pack Number CVI4720B ; 65) KIT LINE INSERTION, Pack Number CVI4730; 66) KIT LINE INSERTION, Pack Number CVI4730A ; 67) VENOUS ACCESS TRAY, Pack Number CVI4830B ; 68) PORT INSERTION PACK , Pack Number CVI4870; 69) MVHS CVC LUMEN TRAY , Pack Number CVI4920; 70) NO CATHETER BUNDLE, Pack Number CVI4925A ; 71) UAMS PORT INSERTION KIT , Pack Number CVI5040; 72) CVL INSERTION PACK, Pack Number CVI5065; 73) CVL INSERTION PACK, Pack Number CVI5065H ; 74) HEMODIALYSIS TRAY , Pack Number DT8800 ; 75) ERCP KIT, Pack Number DYKE1006A; 76) PULMONARY KIT , Pack Number DYKE1870 ; 77) PULMONARY KIT, Pack Number DYKE1870H; 78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A; 79) ULTRASOUND PACK , Pack Number DYNDA1249A ; 80) CT SCAN-TC, Pack Number DYNDA1380A ; 81) CT SCAN-TC, Pack Number DYNDA1380AH; 82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077; 83) BAL KIT , Pack Number DYNDA2137B ; 84) STERILE PRE OP PACK , Pack Number

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 2012

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012