BEUDAMED
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    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVAIHH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Extended Duration, MVAIHL; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Short-term use: Procedural/Emergency, MVAIL; Microstream Advance Air Military Sample Kit CO2 Oral-Nasal Filter Line with O2 Tubing (MVAO) and Adult-Pediatric Intubated Filter Line, High Humidity (MVAIHH) 2m/6.5ft, MVAMSK; Microstream Advance Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connector (MVA) 2m/6.5ft, MVASK; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Extended Duration, ZMVAIH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft High Humidity, ZMVAIHH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, ZMVAI;

    FDA Recall
    Open, Classified ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;

    FDA Recall
    Open, Classified ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624.

    FDA Recall
    Open, Classified ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025

    CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 (INTL) N REFURBISHED, CS78652

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 M NICU (CPM), CS08654RN

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991

    FDA Recall
    Open, Classified ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025

    Capnostream20 (INTL) M REFURBISHED, CS78654

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·July 31, 2018

    Capnostream20 M W/PRINTER CYVITAL, CS08796

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 (US)M REFURBISHED, Part Number CS78653

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 (US) M W/PRINTER, Part Number CS08659

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 N W/PRINTER CYVITAL, CS08798

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·July 31, 2018

    Capnostream20 N CYVITAL, CS08799

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Capnostream20 (INTL) M W/PRINTER, CS08660

    FDA Recall
    Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Television, Less Than 25kv And Less Than 0.1 Mr/Hr

    FDA classification
    FDA Not Classified ·Television, Less Than 25kv And Less Than 0.1 Mr/Hr