Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DreamStation BiPAP AVAPS30 with Cell Modem, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Cell, CA
In Commercial Distribution

  • 00606959045705 ()
CAX1130S12C

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 AAM, with WiFi, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/WiFi, CA
In Commercial Distribution

  • 00606959045675 ()
CAX1130S12W

  • Portable electric ventilator
DreamStation Wi-Fi Accessory with Oximetry, Canada
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, CA
In Commercial Distribution

  • 00606959048980 ()
100710W

  • Medical networking interface unit
DreamStation Go CPAP with Bluetooth, Canada
Respironics, Inc.
DreamStation Go CPAP with Bluetooth, CA
In Commercial Distribution

  • 00606959048607 ()
CAG400S12

  • Home CPAP unit
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Pelvic Positioner Kit With2 Pads And 2 Post Protector Caps Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49482
In Commercial Distribution

  • 20885632448642 ()
  • 10885632448645 ()


  • Freestanding patient positioner, single-use
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387620
In Commercial Distribution

  • 15099590231859 ()
387620

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Frame Sleeves Prone Face Cushion Arm Cradles Pole Protector Drape Protector Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49472
In Commercial Distribution

  • 20885632448574 ()
  • 10885632448577 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Frame Sleeves Comfort Headrest Arm Cradles Pole Protector No Drape Protector Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49471
In Commercial Distribution

  • 20885632448567 ()
  • 10885632448560 ()


  • Freestanding patient positioner, single-use
ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Dual Chest Pillows 4 Hip Thigh Covers Set Of 4 Arm Cradles Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49454
In Commercial Distribution

  • 20885632448482 ()
  • 10885632448485 ()


  • Freestanding patient positioner, single-use
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