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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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Access OV Monitor Calibrators - 15099590232375

The Access OV Monitor Calibrators are intended to calibrate the Access OV Monitor assay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
386358
In Commercial Distribution

  • 15099590232375 ()
386358

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Access BR Monitor Calibrators - 15099590231866

The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387647
In Commercial Distribution

  • 15099590231866 ()
387647

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Access GI Monitor Calibrators - 15099590231835

The Access GI Monitor Calibrators are intended to calibrate the Access GI Monitor assay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387688
In Commercial Distribution

  • 15099590231835 ()
387688

  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

HALYARD - 10885632448546

Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/10 All In One Trendelenberg Pad With Attached Arm Protectors Head Cradle No Strap Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49469
In Commercial Distribution

  • 20885632448543 ()
  • 10885632448546 ()


  • Freestanding patient positioner, single-use

HALYARD - 10885632448539

Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/10 All In One Trendelenberg Pad With Attached Arm Protectors Head Cradle And Strap Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49458
In Commercial Distribution

  • 20885632448536 ()
  • 10885632448539 ()


  • Freestanding patient positioner, single-use

TC-EH DTRS INTFC CA E FOR M NO AMPL W/NEG CAL - 00886333641116

Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684111
In Commercial Distribution

  • 50886333641111 ()
  • 00886333641116 ()

  • cable length 150"
684111

  • Electrical-only medical device connection cable, reusable

System One - 00606959029200

System One Heated Humidifier without Tube, Canada
Respironics, Inc.
System One Heated Humidifier without Tube, CA
In Commercial Distribution

  • 00606959029200 ()
CA6NT

  • Heated respiratory humidifier

EverFlo - 00606959014954

EverFlo Non-O2 Percentage Indicator, 120V, US,CANADA
Respironics, Inc.
EVERFLO NON-O2 Percentage Indicator, 120V, US,CA
In Commercial Distribution

  • 00606959014954 ()
1020000

  • Stationary oxygen concentrator

DreamStation - 00606959040915

DreamStation BiPAP AVAPS 30 with Heated Humdifier, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM w/Humidifier, CA
In Commercial Distribution

  • 00606959040915 ()
CAX1130H12

  • Portable electric ventilator

BIPAP autoSV Advanced System One 60 Series - 00606959038011

BIPAP autoSV Advanced 60 Series 30cm, Canada
Respironics, Inc.
BiPAP autoSV Advnced, 60 Series, 30cm, CA
In Commercial Distribution

  • 00606959038011 ()
961TCA

  • Portable electric ventilator
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