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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Electrodes Deluxe 2"x2" (4pcs.)
VERIDIAN HEALTHCARE LLC
21049
In Commercial Distribution

  • 00682891210494 ()


  • Transcutaneous electrical stimulation electrode, single-use
Electrodes 2"x2" (4pcs.)
VERIDIAN HEALTHCARE LLC
21048
In Commercial Distribution

  • 00682891210487 ()


  • Transcutaneous electrical stimulation electrode, single-use
TENS Unit 21022
VERIDIAN HEALTHCARE LLC
21022
In Commercial Distribution

  • 00682891210227 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
SpaBuddy Sport
VERIDIAN HEALTHCARE LLC
21019
In Commercial Distribution

  • 00682891210197 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
SpaBuddy Relax
VERIDIAN HEALTHCARE LLC
21017
In Commercial Distribution

  • 00682891210173 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
TENS Unit Combo
VERIDIAN HEALTHCARE LLC
21010
In Commercial Distribution

  • 00682891210104 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
TENS Unit Analog
VERIDIAN HEALTHCARE LLC
21007
In Commercial Distribution

  • 00682891210074 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
TENS Unit Digital
VERIDIAN HEALTHCARE LLC
21005
In Commercial Distribution

  • 00682891210050 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
TENS Unit Analog
VERIDIAN HEALTHCARE LLC
21004
In Commercial Distribution

  • 00682891210043 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Infrared Thermometer
VERIDIAN HEALTHCARE LLC
11115
In Commercial Distribution

  • 00682891111159 ()


  • Infrared patient thermometer, ear/skin
Infrared Thermometer
VERIDIAN HEALTHCARE LLC
11110
In Commercial Distribution

  • 00682891111104 ()


  • Infrared patient thermometer, skin
WellCare 7 mil exam Black nitrile gloves, size 2XL, 90pcs/box, 10boxes/case
Wellcare International, Inc.
WBK705
In Commercial Distribution

  • 00682670681910 ()
  • 00682670682658 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Black nitrile gloves, size XL, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WBK704
In Commercial Distribution

  • 00682670681903 ()
  • 00682670682641 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Black nitrile gloves, size L, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WBK703
In Commercial Distribution

  • 00682670681897 ()
  • 00682670682634 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Black nitrile gloves, size M, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WBK702
In Commercial Distribution

  • 00682670681880 ()
  • 00682670682627 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Blue nitrile gloves, size 2XL, 90pcs/box, 10boxes/case
Wellcare International, Inc.
WNB705
In Commercial Distribution

  • 00682670681873 ()
  • 00682670682610 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Blue nitrile gloves, size XL, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WNB704
In Commercial Distribution

  • 00682670681866 ()
  • 00682670682603 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 7 mil exam Blue nitrile gloves, size L, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WNB703
In Commercial Distribution

  • 00682670681859 ()
  • 00682670682597 ()


  • Thermal vapour lung treatment system catheter
WellCare 7 mil exam Blue nitrile gloves, size M, 100pcs/box, 10boxes/case
Wellcare International, Inc.
WNB702
In Commercial Distribution

  • 00682670681842 ()
  • 00682670682580 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
WellCare 5 mil exam Black nitrile gloves, size 2XL, 90pcs/box, 10boxes/case
Wellcare International, Inc.
WNGBK505
In Commercial Distribution

  • 00682670681965 ()
  • 00682670681101 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L031-125P5
In Commercial Distribution

  • 20682607660470 ()
  • 00682607660476 ()
  • 00682607002306 ()
660476

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
Acon Laboratories, Inc.
L031-125N5
In Commercial Distribution

  • 20682607660289 ()
  • 00682607660285 ()
  • 00682607002306 ()
660285

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
Acon Laboratories, Inc.
L031-125M5
In Commercial Distribution

  • 20682607660272 ()
  • 00682607660278 ()
  • 00682607002306 ()
660278

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)
Acon Laboratories, Inc.
L031-118B5
In Commercial Distribution

  • 10682607660268 ()
  • 00682607660261 ()
  • 20682607533262 ()
  • 20682607660265 ()
  • 00682607002306 ()
660261

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Urinary Tract Infection home test with handle
Acon Laboratories, Inc.
725125
In Commercial Distribution

  • 20682607651256 ()
  • 00682607651252 ()
  • 00682607003150 ()
  • 10682607651259 ()


  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
Urinary Tract Infection home test
Acon Laboratories, Inc.
765100
In Commercial Distribution

  • 20682607651003 ()
  • 00682607651009 ()
  • 00682607002085 ()


  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
Early Detection Pregnancy Test
Acon Laboratories, Inc.
L031-20198-102
In Commercial Distribution

  • 00682607630653 ()
  • 00682607003242 ()
  • 10682607630650 ()
  • 20682607630657 ()
763065

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Detection Digital Pregnancy Test
Acon Laboratories, Inc.
L031-20108-103
In Commercial Distribution

  • 10682607630605 ()
  • 00682607630608 ()
  • 20682607630602 ()
  • 00682607003235 ()
763060

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Detection Digital Pregnancy Test
Acon Laboratories, Inc.
L031-20108-102
In Commercial Distribution

  • 10682607630599 ()
  • 00682607630592 ()
  • 20682607630596 ()
  • 00682607003235 ()
763059

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Detection Digital Pregnancy Test
Acon Laboratories, Inc.
L031-20108-101
In Commercial Distribution

  • 10682607630582 ()
  • 00682607630585 ()
  • 20682607630589 ()
763058

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Detection Pregnancy Test
Acon Laboratories, Inc.
L031-20198-103
In Commercial Distribution

  • 20682607630558 ()
  • 10682607630551 ()
  • 00682607630554 ()
  • 00682607003242 ()
763055

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Detection Pregnancy Test
Acon Laboratories, Inc.
L031-20198-101
In Commercial Distribution

  • 10682607630544 ()
  • 00682607630547 ()
  • 20682607630541 ()
763054

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3061
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611144 ()
  • 00682607611140 ()


  • Haemoglobin analyser IVD, point-of-care
Hb Meter, 50 Test Cartridges, 60 Capillary Transfer Tubes, 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3051
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611137 ()
  • 00682607611133 ()


  • Haemoglobin analyser IVD, point-of-care
Hb Meter, vial of 2 Optical Verifiers
Acon Laboratories, Inc.
C112-3041
In Commercial Distribution

  • 00682607000180 ()
  • 20682607611120 ()
  • 00682607611126 ()


  • Haemoglobin analyser IVD, point-of-care
Box of 2 Optical Verifiers (1 vial)
Acon Laboratories, Inc.
C122-3021
In Commercial Distribution

  • 20682607610567 ()
  • 00682607610563 ()
  • 00682607000241 ()


  • Haemoglobin analyser IVD, point-of-care
Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20)
Acon Laboratories, Inc.
C132-3041
In Commercial Distribution

  • 20682607610543 ()
  • 00682607610549 ()
  • 00682607000234 ()


  • Haemoglobin analyser IVD, point-of-care
Box of 50 Test Cartridges (5 vials)
Acon Laboratories, Inc.
C132-3021
In Commercial Distribution

  • 20682607610536 ()
  • 00682607610532 ()
  • 00682607000234 ()


  • Haemoglobin analyser IVD, point-of-care
Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G)
Acon Laboratories, Inc.
G117-10A
In Commercial Distribution

  • 20682607571141 ()
  • 00682607571147 ()
  • 00682607001675 ()
757114

  • Glucose monitoring system IVD, home-use
Blood Glucose Meter
Acon Laboratories, Inc.
G117-14A
In Commercial Distribution

  • 00682607001675 ()
  • 10682607571083 ()
  • 00682607571086 ()
  • 20682607571080 ()
757108

  • Glucose monitoring system IVD, home-use
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