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    19 results · 33ms · Sources: EU EUDAMED, US FDA

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    ABMRC LLC

    FDA registration
    ABMRC LLC·1 product·🇺🇸 United States

    BiWaze Cough

    FDA UDI
    Abmrc LLC·B9652037351818201130·This device is designed for use on patients una...

    BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium

    FDA UDI
    Abmrc LLC·08500501360112·BiWaze Clear Dual Lumen Circuit With Face Mask ...

    BiWaze Cough Dual Lumen Circuit With Mouthpiece

    FDA UDI
    Abmrc LLC·08500501360013·BiWaze Cough Dual Lumen Circuit With Mouthpiece

    BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small

    FDA UDI
    Abmrc LLC·08500501360044·BiWaze Cough Dual Lumen Circuit With Face Mask...

    BiWaze Cough Dual Lumen Circuit With Trach Adapter

    FDA UDI
    Abmrc LLC·08500501360020·BiWaze Cough Dual Lumen Circuit With Trach Ada...

    BiWaze Clear Dual Lumen Circuit With Trach Adapter

    FDA UDI
    Abmrc LLC·08500501360082·BiWaze Clear Dual Lumen Circuit With Trach Adapter

    BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large

    FDA UDI
    Abmrc LLC·08500501360068·BiWaze Cough Dual Lumen Circuit With Face Mask...

    BiWaze Clear Dual Lumen Circuit With Face Mask - Child

    FDA UDI
    Abmrc LLC·08500501360099·BiWaze Clear Dual Lumen Circuit With Face Mask ...

    BiWaze Clear Dual Lumen Circuit With Mouthpiece

    FDA UDI
    Abmrc LLC·08500501360075·BiWaze Clear Dual Lumen Circuit With Mouthpiece

    BiWaze Clear System

    FDA UDI
    Abmrc LLC·B965BK181·The BiWaze Clear System assists patients in loo...

    BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small

    FDA UDI
    Abmrc LLC·08500501360105·BiWaze Clear Dual Lumen Circuit With Face Mask ...

    BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium

    FDA UDI
    Abmrc LLC·08500501360051·BiWaze Cough Dual Lumen Circuit With Face Mask...

    BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large

    FDA UDI
    Abmrc LLC·08500501360129·BiWaze Clear Dual Lumen Circuit With Face Mask ...

    BiWaze Cough Dual Lumen Circuit With Face Mask - Child

    FDA UDI
    Abmrc LLC·08500501360037·BiWaze Cough Dual Lumen Circuit With Face Mask...

    BIWAZE

    FDA Adverse Event
    Malfunction ·ABMRC LLC·Product code NHJ·October 22, 2025

    BIWAZE CLEAR SYSTEM

    FDA Adverse Event
    Malfunction ·ABMRC LLC·Product code NHJ·March 10, 2025

    BIWAZE

    FDA Adverse Event
    Malfunction ·ABMRC LLC·Product code NHJ·February 11, 2025

    Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFK·April 21, 2026