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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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ALIMED, INC.
127104
In Commercial Distribution

  • 00733657287899 ()
  • 00733657300574 ()
2970000186

  • Gel-filled chair cushion
RAPIDLyte Multicap blood collection capillary tubes (100 tubes) approx. volume 60µL. Each tube contains 130-200 I.U./mL Na+/Li+/Ca++ heparin, titrated with KCl. For capillary blood collection for the analysis of pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10314213
In Commercial Distribution

  • 00630414108766 ()
  • 00630414009414 ()
473823

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
ECG Electrode Resting Tab High Adhesion PET White 100 per Pack CA 4000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49990
In Commercial Distribution

  • 40885632398132 ()
  • 20885632398138 ()
  • 30885632398135 ()
  • 10885632398131 ()


  • Electrocardiographic electrode, single-use
Equipment Cover Cover Clear Polyurethane 10IN x 16IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56055
In Commercial Distribution

  • 10885632426599 ()
  • 20885632426596 ()


  • Sharp surgical instrument counting tray/pad, single-use
Equipment Cover Cover Clear Polyurethane 30IN x 14IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56054
In Commercial Distribution

  • 10885632426582 ()
  • 20885632426589 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Cover Clear Polyurethane 22IN x 20IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56053
In Commercial Distribution

  • 10885632426575 ()
  • 20885632426572 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Cover Clear Polyurethane 14IN x 30IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56052
In Commercial Distribution

  • 10885632426568 ()
  • 20885632426565 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Cover Clear Polyurethane 5IN x 72IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56051
In Commercial Distribution

  • 10885632426551 ()
  • 20885632426558 ()


  • Medical equipment/instrument drape, single-use
RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill Solution for in vitro diagnostic use on RAPIDLab® 348/348EX analyzers
Siemens Healthcare Diagnostics Inc.
10311047
In Commercial Distribution

  • 00630414194455 ()
  • 00630414010076 ()
478535

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
AN1004.01 EOGas 4 Refill Kit, CA, 16 EO 17.6g cartridges, 16 AN1087 Dosimeters, 16 Humidichips, 17 EOGas 4 sterilization bags
ANDERSEN STERILIZERS INC.
AN1004.01
In Commercial Distribution

  • 05060485030454 ()
AN1004.01

  • Ethylene oxide sterilizer
Foam Positioner Extremity XL Polyurethane Foam Blue White 2PK CA/20 Extremity Positioners Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49450
In Commercial Distribution

  • 20885632444736 ()
  • 10885632444739 ()


  • Freestanding patient positioner, single-use
120IN EXPANDABLE BREATHING CIRCUIT DUAL LIMB 120IN POLYURETHANE Single-Use CA/20 ADULT EXP Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
ABC1004
In Commercial Distribution

  • 20885632439251 ()
  • 10885632439254 ()


  • Anaesthesia breathing circuit, single-use
Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cartridge tip, MicroGlide GF, and a disposable sleeve.
ECLIPSE
MP1002-CA-K1GF
Not in Commercial Distribution

  • 00853602008215 ()

  • Weight: 24.8 Gram
  • Depth: 1.000 Inch
  • Width: 2.000 Inch
  • Height: 4.500 Inch
MP1002-CA-K1GF

  • Cosmetic micro-needling electronic handpiece cartridge, professional
Series 1 400 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007770 ()
C14T432531

  • Operating room light
Series 1 300 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001037 ()
C13T432531

  • Operating room light
Series 1 200 DT trpl CA 1150 1000 850 9p Dual yk 30M 3P Dual yk 30M Gen 2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007350 ()
C12T432531

  • Operating room light
Intermittent Hydrophilic Catheter Male Coude 18FR 16IN PVC CLEAR Polyacrylamide coating CA/300 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55800
In Commercial Distribution

  • 30885632423653 ()
  • 10885632423659 ()
  • 20885632423656 ()


  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
Intermittent Hydrophilic Catheter Male Coude 16FR 16IN PVC CLEAR Polyacrylamide coating CA/300 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55798
In Commercial Distribution

  • 30885632423646 ()
  • 10885632423642 ()
  • 20885632423649 ()


  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
Intermittent Hydrophilic Catheter Male Coude 10FR 16IN PVC CLEAR Polyacrylamide coating CA/300 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55794
In Commercial Distribution

  • 30885632423615 ()
  • 10885632423611 ()
  • 20885632423618 ()


  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
Film Dressing Transparent Sterile 3.5 X 4.5 Inch NonWoven Transparent CA/200 Sterile Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55560
In Commercial Distribution

  • 20885632416283 ()
  • 10885632416286 ()
  • 30885632416280 ()


  • Synthetic polymer semi-permeable film dressing, adhesive
Film Dressing Transparent Sterile 2.5 X 2.75 Inch NonWoven Transparent CA/400 Sterile Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55559
In Commercial Distribution

  • 20885632416276 ()
  • 10885632416279 ()
  • 30885632416273 ()


  • Synthetic polymer semi-permeable film dressing, adhesive
Volumetric Incentive Spirometer 2500 mL Non Valved Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56181
In Commercial Distribution

  • 20885632429801 ()
  • 10885632429804 ()


  • Diagnostic spirometer, professional
Volumetric Incentive Spirometer 4000 mL Non Valved Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56180
In Commercial Distribution

  • 20885632429795 ()
  • 10885632429798 ()


  • Diagnostic spirometer, professional
Equipment Cover Cover Clear Polyurethane 30IN x 14IN Polyurethane Clear Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56048
In Commercial Distribution

  • 20885632426541 ()
  • 10885632426544 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Cover Clear Polyurethane 5IN x 72IN Polyurethane Clear Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56047
In Commercial Distribution

  • 20885632426534 ()
  • 10885632426537 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Band Bags Clear Polyurethane 12 x 12 Clear Sterile CA/25 Not made with Natural Rubber Latex HYH
OWENS & MINOR DISTRIBUTION, INC.
55833
In Commercial Distribution

  • 20885632425094 ()
  • 10885632425097 ()


  • Medical equipment/instrument drape, single-use
PERINEAL PACK LARGE 6X14IN UREA BLEND CA 24 WITH ADHESIVE STRIP SINGLE PT Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51793
In Commercial Distribution

  • 20885632413923 ()
  • 10885632413926 ()


  • Hot/cold therapy pack, single-use
INSTANT WARM PACK MEDIUM 4X9 IN SODIUM ACETATE CA 24 SINGLE PT USE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51789
In Commercial Distribution

  • 20885632413886 ()
  • 10885632413889 ()


  • Hot/cold therapy pack, single-use
INFANT HEEL WARMER DISC ACTIVATED 3.5X5.5IN SODIUM ACETATE CA 100 ACTIVATED LIQUID SINGLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51784
In Commercial Distribution

  • 20885632413831 ()
  • 30885632413838 ()
  • 10885632413834 ()


  • Hot/cold therapy pack, single-use
INSTANT COLD PACK WITH SLEEVE 6X9IN UREA BLEND CA 24 SINGLE PT USE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51779
In Commercial Distribution

  • 20885632413787 ()
  • 10885632413780 ()


  • Hot/cold therapy pack, single-use
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