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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BIOPTY-CUT® Disposable Core Biopsy Needle, 18g x 25cm
Bard Peripheral Vascular, Inc.
441825
Not in Commercial Distribution

  • 10801741084055 ()
  • 00801741084058 ()

  • Needle Gauge: 18 Gauge
  • Length: 25 Centimeter
441825

  • Side-notch biopsy gun needle
6.6F Broviac CV Catheters 1.0mm Lumen (White Adapter) Repair Kit
Bard Access Systems, Inc.
0601620
In Commercial Distribution

  • 10801741074476 ()
  • 00801741074479 ()

  • Catheter Gauge: 6.6 French
0601620

  • Central venous catheter repair kit
PinPnt Gelcap w/ndleguid 1-1.5cm20-22Ga.50Proc
Bard Access Systems, Inc.
9A10211
In Commercial Distribution

  • 10801741091220 ()
  • 00801741091223 ()

  • Depth: 1 Centimeter
  • Needle Gauge: 20 Gauge
  • Depth: 1.5 Centimeter
  • Depth: 1.25 Centimeter
  • Needle Gauge: 22 Gauge
9A10211

  • Skin topical coupling gel
BardPort Titanium Implantable Port with Attachable 14.3F Open-Ended Single-Lumen Peritoneal Catheter (No Cuff) Basic Kit
Bard Access Systems, Inc.
0603006
In Commercial Distribution

  • 10801741025799 ()
  • 00801741025792 ()

  • Catheter Gauge: 14.3 French
0603006

  • Vascular port/catheter
BARD® JAVID™ Carotid Bypass Shunt, 17F - 10F x 27.5cm
Bard Peripheral Vascular, Inc.
007714
Not in Commercial Distribution

  • 10801741090117 ()
  • 00801741090110 ()

  • External Diameter - 17 French to 10 French
  • Length: 27.5 Centimeter
007714

  • Carotid artery shunt
MAGNUM® Disposable Core Tissue Biopsy Needle, 18g x 30cm
Bard Peripheral Vascular, Inc.
MN1830
In Commercial Distribution

  • 10801741084376 ()
  • 00801741084379 ()

  • Length: 30 Centimeter
  • Needle Gauge: 18 Gauge
MN1830

  • Side-notch biopsy gun needle
Bard® Push Catheter
C. R. Bard, Inc.
888888
In Commercial Distribution

  • 10801741039222 ()
  • 00801741039225 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4.7 French
888888

  • Ureteral stent-placement set
21G Needle Guide Kit w/ 96" Cover, Deep
Bard Access Systems, Inc.
9770693
In Commercial Distribution

  • 10801741138185 ()
  • 00801741138188 ()

  • Needle Gauge: 21 Gauge
  • Depth: 3.5 Centimeter
  • Depth: 2.5 Centimeter
  • Length: 96 Inch
  • Depth: 3 Centimeter
9770693

  • Needle guide, single-use
Bard® CritiCore® Surgipak®System with Bardex® LubriCath® Temperature Sensing Catheter
C. R. Bard, Inc.
900318
Not in Commercial Distribution

  • 10801741019347 ()
  • 00801741019340 ()

  • Catheter Gauge: 18 French
900318

  • Indwelling urethral catheterization kit, adult
  • Urine monitoring system
PowerFlow 9.6Fr ChronoFlex Implantable Apheresis IV Port Intermediate Kit
Bard Access Systems, Inc.
A710962
In Commercial Distribution

  • 10801741129435 ()
  • 00801741129438 ()

  • Catheter Gauge: 9.6 French
  • Length: 45 Centimeter
A710962

  • Apheresis kit
Bile Bag
C. R. Bard, Inc.
0015850
In Commercial Distribution

  • 10801741011617 ()
  • 00801741011610 ()

  • Length: 9.5 Inch
  • Total Volume: 19 Fluid Ounce
0015850

  • Closed-wound/centesis drainage receptacle
Sherlock 3CG Procedure Kit
Bard Access Systems, Inc.
1000118
In Commercial Distribution

  • 10801741136815 ()
  • 00801741136818 ()

  • Length: 78.5 Centimeter
  • Outer Diameter: 0.49 Millimeter
1000118

  • Vascular catheter stylet
PrecisionPass Lap Delivery Device
Davol Inc.
0118101
Not in Commercial Distribution

  • 10801741031158 ()
  • 00801741031151 ()

  • Lumen/Inner Diameter: 20 Millimeter
0118101

  • Surgical mesh laparoscopic delivery/positioning device
Laparoscopic Suction Connecting Tubing
Davol Inc.
0038140
In Commercial Distribution

  • 10801741065221 ()
  • 00801741065224 ()

  • Length: 2 Feet
  • Lumen/Inner Diameter: 5 Millimeter
0038140

  • Disposable vacuum tubing
1530S-1, 1 in x 1.5 yd (2,5 cm x 1,37 m), Unpackaged Rolls, 100 RL/Carton, 5 Cartons/Case, 500 RL/CA
3M Deutschland GmbH
1530S-1
In Commercial Distribution

  • 50707387810035 ()
  • 00707387810030 ()
  • 00707387810023 ()
1530S-1

  • Dressing-fixation skin adhesive tape, non-silicone
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360009
In Commercial Distribution

  • 08426950554691 ()
00027360009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445009
In Commercial Distribution

  • 08426950554769 ()
00027445009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430009
In Commercial Distribution

  • 08426950554745 ()
00027430009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415009
In Commercial Distribution

  • 08426950554738 ()
00027415009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407509
In Commercial Distribution

  • 08426950554707 ()
00027407509

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445008
In Commercial Distribution

  • 08426950807797 ()
00055445008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430008
In Commercial Distribution

  • 08426950807735 ()
00055430008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415008
In Commercial Distribution

  • 08426950807674 ()
00055415008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407508
In Commercial Distribution

  • 08426950807612 ()
00055407508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 - 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360008
In Commercial Distribution

  • 08426950807575 ()
00055360008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Volumetric Incentive Spirometer 2500 mL with One Way Valve Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56179
In Commercial Distribution

  • 20885632429788 ()
  • 10885632429781 ()


  • Diagnostic spirometer, professional
Volumetric Incentive Spirometer with One Way Valve 4000 mL Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56178
In Commercial Distribution

  • 20885632429771 ()
  • 10885632429774 ()


  • Diagnostic spirometer, professional
Foam Positioner Straps Blue White 22X2 IN Polyurethane Foam Blue White CA/50 POSITIONING STRAPS Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49492
In Commercial Distribution

  • 20885632448697 ()
  • 10885632448690 ()


  • Freestanding patient positioner, single-use
INSTANT COLD PACK LARGE 6X9 IN UREA BLEND CA 24 NO SLEEVE SINGLE PT USE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51787
In Commercial Distribution

  • 20885632413862 ()
  • 10885632413865 ()


  • Hot/cold therapy pack, single-use
PERINEAL PACK COLD 4X11IN UREA BLEND CA 24 PAD W/AD STRIP REG SINGLE PT Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51773
In Commercial Distribution

  • 20885632413756 ()
  • 10885632413759 ()


  • Hot/cold therapy pack, single-use
Bordered Gauze Adhesive Island Dressing 4x4 Square gauze white CA/200 Sterile Bordered Gauze White NOT MADE WITH NaTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
50195
In Commercial Distribution

  • 20885632406888 ()
  • 10885632406881 ()
  • 30885632406885 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Bordered Gauze Adhesive Island Dressing 2x2 Square gauze white CA/400 Sterile Bordered Gauze White NOT MADE WITH Natural RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
50194
In Commercial Distribution

  • 30885632406878 ()
  • 20885632406871 ()
  • 10885632406874 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Equipment Cover Set Up Cover Clear Polyurethane 70IN x 70IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56157
In Commercial Distribution

  • 10885632426926 ()
  • 20885632426923 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 54IN x 90IN Polyurethane Clear Non-Sterile CA/40 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56156
In Commercial Distribution

  • 10885632426919 ()
  • 20885632426916 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 54IN x 80IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56155
In Commercial Distribution

  • 10885632426902 ()
  • 20885632426909 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 54IN x 70IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56154
In Commercial Distribution

  • 10885632426896 ()
  • 20885632426893 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 54IN x 54IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56153
In Commercial Distribution

  • 10885632426889 ()
  • 20885632426886 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 44IN x 90IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56145
In Commercial Distribution

  • 10885632426872 ()
  • 20885632426879 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 44IN x 70IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56144
In Commercial Distribution

  • 10885632426865 ()
  • 20885632426862 ()


  • Medical equipment/instrument drape, single-use
Exam Shorts SMS Elastic Waistband Meduim Dark Blue 1/EA 25PK 100 CA 35gsm Disposable Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
ES3503
In Commercial Distribution

  • 30885632291160 ()
  • 20885632291163 ()
  • 10885632291166 ()


  • Isolation gown, single-use
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