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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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Nemoto 100ml/200mL Dual Pack w/ fill tube
COEUR, INC.
C855-5304
In Commercial Distribution

  • M902553046 ()
  • M902553040 ()

  • Total Volume: 200 Milliliter
  • Total Volume: 100 Microliter
C855-5304

  • Angiographic syringe
200mL /50mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes
COEUR, INC.
C855-5258
In Commercial Distribution

  • M902552586 ()
  • M902552580 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 200 Milliliter
C855-5258

  • Angiographic syringe
Nemoto 200ml w/ coiled line and fill tube
COEUR, INC.
C855-5202
In Commercial Distribution

  • M902552026 ()
  • M902552020 ()

  • Total Volume: 200 Milliliter
C855-5202

  • Angiographic syringe
200mL Disposable Syringe
COEUR, INC.
C855-5200
In Commercial Distribution

  • M902552006 ()
  • M902552000 ()

  • Total Volume: 200 Milliliter
C855-5200

  • Angiographic syringe
100mL/100mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes
COEUR, INC.
C855-5178
In Commercial Distribution

  • M902551786 ()
  • M902551780 ()

  • Total Volume: 100 Milliliter
C855-5178

  • Angiographic syringe
100mL/50mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes
COEUR, INC.
C855-5155
In Commercial Distribution

  • M902551556 ()
  • M902551550 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 100 Milliliter
C855-5155

  • Angiographic syringe
100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike
COEUR, INC.
C855-5106
In Commercial Distribution

  • M902551066 ()
  • M902551060 ()

  • Total Volume: 100 Milliliter
C855-5106

  • Angiographic syringe
100mL Disposable Syringe includes (1) fill tube
COEUR, INC.
C855-5101
In Commercial Distribution

  • M902551016 ()
  • M902551010 ()

  • Total Volume: 100 Milliliter
C855-5101

  • Angiographic syringe
immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
LUMIQUICK DIAGNOSTICS, INC.
W1-C
In Commercial Distribution

  • M901W1C0 ()
  • M901W1C1 ()

  • Length: 80 Millimeter
W1-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
74046-II
In Commercial Distribution

  • M90174046II0 ()
  • M90174046II1 ()

  • Length: 74 Millimeter
74046-II

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7205-02
In Commercial Distribution

  • M90107RD7205021 ()
  • M90107RD7205020 ()

  • Length: 74 Millimeter
07RD7205-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
200mL/200mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Spikes
COEUR, INC.
C855-5408
In Commercial Distribution

  • M902554086 ()
  • M902554080 ()

  • Total Volume: 200 Milliliter
C855-5408

  • Angiographic syringe
200mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes
COEUR, INC.
C855-5308
In Commercial Distribution

  • M902553086 ()
  • M902553080 ()

  • Total Volume: 100 Milliliter
  • Total Volume: 200 Milliliter
C855-5308

  • Angiographic syringe
200mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike
COEUR, INC.
C855-5206
In Commercial Distribution

  • M902552066 ()
  • M902552060 ()

  • Total Volume: 200 Milliliter
C855-5206

  • Angiographic syringe
200mL Disposable CT Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5201
In Commercial Distribution

  • M902552016 ()
  • M902552010 ()

  • Total Volume: 200 Milliliter
C855-5201

  • Angiographic syringe
100mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (1) J-Tube
COEUR, INC.
C855-5174
In Commercial Distribution

  • M902551746 ()
  • M902551740 ()

  • Total Volume: 100 Milliliter
C855-5174

  • Angiographic syringe
150mL Disposable Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5150
In Commercial Distribution

  • M902551506 ()
  • M902551500 ()

  • Total Volume: 150 Milliliter
C855-5150

  • Angiographic syringe
125mL Disposable Angiographic Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5125
In Commercial Distribution

  • M902551256 ()
  • M902551250 ()

  • Total Volume: 125 Milliliter
C855-5125

  • Angiographic syringe
100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Tube
COEUR, INC.
C855-5102
In Commercial Distribution

  • M902551026 ()
  • M902551020 ()
C855-5102

  • Angiographic syringe
100mL Disposable Syringe
COEUR, INC.
C855-5100
In Commercial Distribution

  • M902551006 ()
  • M902551000 ()

  • Total Volume: 100 Milliliter
C855-5100

  • Angiographic syringe
50mL /50mL Disposable MR Dual Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (2) Spikes
COEUR, INC.
C855-5079
In Commercial Distribution

  • M902550796 ()
  • M902550790 ()

  • Total Volume: 50 Milliliter
C855-5079

  • Angiographic syringe
50mL Disposable MR Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (1) Spike
COEUR, INC.
C855-5059
In Commercial Distribution

  • M902550590 ()
  • M902550596 ()

  • Total Volume: 50 Milliliter
C855-5059

  • Angiographic syringe
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7184-02A
In Commercial Distribution

  • M90107RD718402A1 ()
  • M90107RD718402A0 ()

  • Length: 75 Millimeter
07RD7184-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM137544S
In Commercial Distribution

  • H965PKM137544S1 ()
  • PKM137544S0 ()

  • Catheter Gauge: 4 French
  • Length: 55 Centimeter
  • Single


  • Peripherally-inserted central venous catheter
Kroger Twist Lancets 33g
MHC MEDICAL PRODUCTS, LLC
933101
In Commercial Distribution

  • MHC19331013 ()
  • MHC19331012 ()
  • MHC19331010 ()
933101

  • Blood lancet, single-use
Kroger Twist Lancets 30g
MHC MEDICAL PRODUCTS, LLC
930101
In Commercial Distribution

  • MHC19301013 ()
  • MHC19301012 ()
  • MHC19301010 ()
930101

  • Blood lancet, single-use
Kroger Twist Lancets 26g
MHC MEDICAL PRODUCTS, LLC
926101
In Commercial Distribution

  • MHC19261012 ()
  • MHC19261010 ()
  • MHC19261013 ()
926101

  • Blood lancet, single-use
Kroger Glucose Test Strip (100ct)
MHC MEDICAL PRODUCTS, LLC
909100
In Commercial Distribution

  • MHC19091003 ()
  • MHC19091002 ()
  • MHC19091000 ()
909100

  • Blood glucose/blood pressure monitoring system, home-use
Kroger Glucose Test Strip (50ct)
MHC MEDICAL PRODUCTS, LLC
909050
In Commercial Distribution

  • MHC19090503 ()
  • MHC19090502 ()
  • MHC19090500 ()
909050

  • Blood glucose/blood pressure monitoring system, home-use
Kroger Glucose Test Strip (25ct)
MHC MEDICAL PRODUCTS, LLC
909025
In Commercial Distribution

  • MHC19090253 ()
  • MHC19090252 ()
  • MHC19090250 ()
909025

  • Blood glucose/blood pressure monitoring system, home-use
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