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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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Clear-View Subcutaneous Infusion Set - M991CVS133301

27G x 12mm x 1" Clear-View "Sub-Q" Infusion Set w/ Extension Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS133303 ()
  • M991CVS133302 ()
  • M991CVS133301 ()

  • Needle Gauge: 27 Gauge
CVS13330

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS13230NES1

27G x 9mm x 1" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS13230NES2 ()
  • M991CVS13230NES1 ()
  • M991CVS13230NES3 ()

  • Needle Gauge: 27 Gauge
CVS13230NES

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS132301

27G x 9mm x 1" Clear-View "Sub-Q" Infusion Set w/ Extension Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS132303 ()
  • M991CVS132302 ()
  • M991CVS132301 ()

  • Needle Gauge: 27 Gauge
CVS13230

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS13130NES1

27G x 6mm x 1" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS13130NES3 ()
  • M991CVS13130NES2 ()
  • M991CVS13130NES1 ()

  • Needle Gauge: 27 Gauge
CVS13130NES

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS131301

27G x 6mm x 1" Clear-View "Sub-Q" Infusion Set w/ Extension Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS131302 ()
  • M991CVS131301 ()
  • M991CVS131303 ()

  • Needle Gauge: 27 Gauge
CVS13130

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS12130NES1

24G x 6mm x 1" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS12130NES1 ()
  • M991CVS12130NES2 ()
  • M991CVS12130NES3 ()

  • Needle Gauge: 24 Gauge
CVS12130NES

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS033301

27G x 12mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS033302 ()
  • M991CVS033301 ()
  • M991CVS033303 ()

  • Needle Gauge: 27 Gauge
CVS03330

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS032301

27G x 9mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS032302 ()
  • M991CVS032301 ()
  • M991CVS032303 ()

  • Needle Gauge: 27 Gauge
CVS03230

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS031301

27G x 6mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS031302 ()
  • M991CVS031301 ()
  • M991CVS031303 ()

  • Needle Gauge: 27 Gauge
CVS03130

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS024301

24G x 4mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS024303 ()
  • M991CVS024302 ()
  • M991CVS024301 ()

  • Needle Gauge: 24 Gauge
CVS02430

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS023301

24G x 12mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS023303 ()
  • M991CVS023302 ()
  • M991CVS023301 ()

  • Needle Gauge: 24 Gauge
CVS02330

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS022301

24G x 9mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS022303 ()
  • M991CVS022302 ()
  • M991CVS022301 ()

  • Needle Gauge: 24 Gauge
CVS02230

  • Electric infusion pump administration set, single-use

Clear-View Subcutaneous Infusion Set - M991CVS021301

24G x 6mm x 6" Clear-View "Sub-Q" Infusion Set
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution

  • M991CVS021301 ()
  • M991CVS021302 ()
  • M991CVS021303 ()

  • Needle Gauge: 24 Gauge
CVS02130

  • Electric infusion pump administration set, single-use

Bowie Dick Type Test - M985CIBDTLF0

ProChem B-D Bowie Dick Type Test pack
MESA LABORATORIES, INC.
ProChem
In Commercial Distribution

  • M985CIBDTLF0 ()
  • M985CIBDTLF2 ()
  • M985CIBDTLF1 ()
CI-BDTLF

  • Chemical/physical sterilization process indicator

MesaLabs - M985065003210

pHoenix Dialysate Meter
MESA LABORATORIES, INC.
06.500321
In Commercial Distribution

  • M985065003210 ()
  • M9850600030 ()
  • M9850600390 ()
06.500321

  • Multi-parameter device tester

Coeur Nemoto - M902550500

50mL Disposable Syringe
COEUR, INC.
C855-5050
In Commercial Distribution

  • M902550506 ()
  • M902550505 ()
  • M902550500 ()

  • Total Volume: 50 Milliliter
C855-5050

  • Angiographic syringe

Coeur/Nemoto - M902124200

1200 PSI High Pressure Y-Line with Rotating Adapter
COEUR, INC.
C453-2420
In Commercial Distribution

  • M902124206 ()
  • M902124205 ()
  • M902124200 ()
C453-2420

  • Radiographic procedure tubing

Coeur Nemoto - M902121510

60” (1500mm) 300psi Extension Y-Line with Check Valve
COEUR, INC.
C455-2151
In Commercial Distribution

  • M902121516 ()
  • M902121515 ()
  • M902121510 ()

  • Length: 60 Inch
C455-2151

  • Radiographic procedure tubing

Coeur Nemoto - M902115000

60” (1500mm) 330psi Extension Line
COEUR, INC.
C455-1500
In Commercial Distribution

  • M902115006 ()
  • M902115005 ()
  • M902115000 ()

  • Length: 60 Inch
C455-1500

  • Radiographic procedure tubing

Coeur Nemoto - M902109040

8” Fill Tube
COEUR, INC.
C455-0904
In Commercial Distribution

  • M902109046 ()
  • M902109045 ()
  • M902109040 ()

  • Length: 8 Inch
C455-0904

  • Radiographic procedure tubing

Coeur Nemoto - M902100600

60” (1500mm) 330psi Coiled Connector Tube
COEUR, INC.
C455-0060
In Commercial Distribution

  • M902100606 ()
  • M902100605 ()
  • M902100600 ()

  • Length: 60 Inch
C455-0060

  • Radiographic procedure tubing

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979500341

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. 34" MLPS.
Delfi Medical Innovations Inc
9-7950-034
In Commercial Distribution

  • M995979500341 ()
  • M995979501343 ()
  • M995979500343 ()


  • Stockinette

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979500181

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. 18" MLPS.
Delfi Medical Innovations Inc
9-7950-018
In Commercial Distribution

  • M995979500181 ()
  • M995979501183 ()
  • M995979500183 ()


  • Stockinette

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979500241

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. 24" MLPS.
Delfi Medical Innovations Inc
9-7950-024
In Commercial Distribution

  • M995979500241 ()
  • M995979501243 ()
  • M995979500243 ()


  • Stockinette

QuickProfile™ Oxycodone Test Card - M90107RD71010

Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7101
In Commercial Distribution

  • M90107RD71011 ()
  • M90107RD71010 ()
  • M90107RD71012 ()

  • Length: 75 Millimeter
07RD7101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 6 Test - M90107RD7065390

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-39
In Commercial Distribution

  • M90107RD7065391 ()
  • M90107RD7065390 ()
  • M90107RD7065392 ()

  • Length: 75 Millimeter
07RD7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 5 Test - M90107RD7064050

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC/ OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution

  • M90107RD7064051 ()
  • M90107RD7064050 ()
  • M90107RD7064052 ()

  • Length: 75 Millimeter
07RD7064-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Britedent - D974BSI20051

Micro Applicators Regular (2.00mm) Orange
Bright Supply, Inc.
BSI-2005
In Commercial Distribution

  • D974BSI20052 ()
  • D974BSI20051 ()
  • D974BSI20053 ()
  • D974BSI20050 ()


  • Dental material application tool, single-use

Britedent - D974BSI00061

Cotton Tipped applicator 6" small tip.
Bright Supply, Inc.
BSI-0006
In Commercial Distribution

  • D974BSI00062 ()
  • D974BSI00060 ()
  • D974BSI00061 ()
  • D974BSI00063 ()


  • General-purpose absorbent tip applicator/swab, single-use
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