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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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AirLife™ - 10889483584118

Tracheostomy Cleaning Tray
AIRLIFE
4681A
In Commercial Distribution

  • 30889483584112 ()
  • 10889483584118 ()
  • 10190752142114 ()
4681A

  • Tracheostomy care kit, single-use

Vital Signs™ - 10889483583388

Vital Signs™ Patient Hytrel Tube, Pediatric, Reusable 1500 mm/ 59 in, connectors 22/15 mm
AirLife Finland Oy
427010700
In Commercial Distribution

427010700

  • Inspiratory/expiratory limb respiratory tubing, reusable

AirLife™ - 10889483581520

Tracheostomy Care Kit
AIRLIFE
3T4692
In Commercial Distribution

  • 30889483581524 ()
  • 10889483581520 ()
  • 10190752141957 ()
3T4692

  • Tracheostomy care kit, single-use

AirLife™ - 10889483581513

Basic Tracheostomy Care Kit
AIRLIFE
3T4691A
In Commercial Distribution

  • 30889483581517 ()
  • 10889483581513 ()
  • 10190752142015 ()
3T4691A

  • Tracheostomy care kit, single-use

AirLife™ - 10889483580035

AirLife™ Pediatric Mouth-to-Mask Resuscitator Oxygen Port, Filter, 6 inch (15 cm) Tubing, Mouthpiece
AIRLIFE
2K8013
In Commercial Distribution

  • 30889483580039 ()
  • 10889483580035 ()
2K8013

  • Pulmonary resuscitator, manual, single-use

Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) - 05055273219203

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAE10627
In Commercial Distribution

  • 05055273219203 ()
LAE10627

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) - 05055273219197

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAN10626
In Commercial Distribution

  • 05055273219197 ()
LAN10626

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) - 05055273219180

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAL10625
In Commercial Distribution

  • 05055273219180 ()
LAL10625

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) - 05055273219173

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAE10567
In Commercial Distribution

  • 05055273219173 ()
LAE10567

  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) - 05055273219166

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAN10566
In Commercial Distribution

  • 05055273219166 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) - 05055273219159

The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
LAL10565
In Commercial Distribution

  • 05055273219159 ()
LAL10565

  • Multiple-type clinical chemistry analyte profile IVD, control

APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) - 05055273216448

Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for Apolipoprotein A1 and Apolipoprotein B.
RANDOX LABORATORIES LIMITED
LV10363
In Commercial Distribution

  • 05055273216448 ()
LV10363

  • Multiple apolipoprotein IVD, control

ADIPONECTIN CONTROL - LEVEL 3 (ADPN CONTROL 3) - 05055273213928

No Description
RANDOX LABORATORIES LIMITED
AO2802
In Commercial Distribution

  • 05055273213928 ()


  • Adiponectin IVD, control

ADIPONECTIN CONTROL - LEVEL 2 (ADPN CONTROL 2) - 05055273213911

No Description
RANDOX LABORATORIES LIMITED
AO2801
In Commercial Distribution

  • 05055273213911 ()


  • Adiponectin IVD, control

ADIPONECTIN CALIBRATOR (ADPN CAL) - 05055273213904

No Description
RANDOX LABORATORIES LIMITED
AO2800
In Commercial Distribution

  • 05055273213904 ()


  • Adiponectin IVD, calibrator

ALKALINE DETERGENT (Alkaline Detergent) - 05055273210385

Alkaline Detergent is used for cleaning the instrument probe and reaction cuvettes.
RANDOX LABORATORIES LIMITED
RX8108
In Commercial Distribution

  • 05055273210385 ()
RX8108

  • Wash/cleaning solution IVD, automated/semi-automated system

ANTI-BACTERIAL DETERGENT (Detergent) - 05055273210378

Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes.
RANDOX LABORATORIES LIMITED
RX8106
In Commercial Distribution

  • 05055273210378 ()
RX8106

  • Wash/cleaning solution IVD, automated/semi-automated system

URIC ACID (UA) - 05055273209570

No Description
RANDOX LABORATORIES LIMITED
UA8333
In Commercial Distribution

  • 05055273209570 ()


  • Uric acid IVD, kit, spectrophotometry

URIC ACID (UA) - 05055273209563

No Description
RANDOX LABORATORIES LIMITED
UA8069
In Commercial Distribution

  • 05055273209563 ()


  • Uric acid IVD, kit, spectrophotometry

APOLIPOPROTEIN B (APO B) - 05055273209228

No Description
RANDOX LABORATORIES LIMITED
LP8008
In Commercial Distribution

  • 05055273209228 ()


  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

APOLIPOPROTEIN A-I (APO A-I) - 05055273209211

No Description
RANDOX LABORATORIES LIMITED
LP8007
In Commercial Distribution

  • 05055273209211 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) - 05055273209204

No Description
RANDOX LABORATORIES LIMITED
LP5047
In Commercial Distribution

  • 05055273209204 ()


  • Multiple apolipoprotein IVD, calibrator

ANTI-STREPTOLYSIN-O 2 (ASO 2) - 05055273209181

No Description
RANDOX LABORATORIES LIMITED
LO8305
In Commercial Distribution

  • 05055273209181 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

ANTI-STREPTOLYSIN-O 2 (ASO 2) - 05055273209174

No Description
RANDOX LABORATORIES LIMITED
LO8015
In Commercial Distribution

  • 05055273209174 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) - 05055273209129

No Description
RANDOX LABORATORIES LIMITED
LE5018
In Commercial Distribution

  • 05055273209129 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2) - 05055273209112

No Description
RANDOX LABORATORIES LIMITED
LE5017
In Commercial Distribution

  • 05055273209112 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) - 05055273209105

No Description
RANDOX LABORATORIES LIMITED
LE5016
In Commercial Distribution

  • 05055273209105 ()


  • Multiple apolipoprotein IVD, control

ASPARTATE AMINOTRANSFERASE (AST) - 05055273208238

No Description
RANDOX LABORATORIES LIMITED
AS8005
In Commercial Distribution

  • 05055273208238 ()


  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

ALKALINE PHOSPHATASE (ALP) - 05055273208207

No Description
RANDOX LABORATORIES LIMITED
AP8302
In Commercial Distribution

  • 05055273208207 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

ALANINE AMINOTRANSFERASE (ALT) - 05055273208160

No Description
RANDOX LABORATORIES LIMITED
AL8304
In Commercial Distribution

  • 05055273208160 ()


  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
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