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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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CUSTOM PACK CB9L24R 5PK L I M B
MEDTRONIC, INC.
CB9L24R
In Commercial Distribution

  • 20643169855186 ()
  • 00643169855175 ()


  • Cardiopulmonary bypass system blood tubing set
Mach I OTC BTE Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0005-21
In Commercial Distribution

  • 00850049194150 ()


  • Air-conduction hearing aid, behind-the-ear
Mach I OTC BTE Hearing Aids, Pair - Slate
Novidan, Inc.
99-0005-20
In Commercial Distribution

  • 00850049194143 ()


  • Air-conduction hearing aid, behind-the-ear
Mach I OTC BTE Hearing Aids, Pair - Beige
Novidan, Inc.
99-0005-19
In Commercial Distribution

  • 00850049194136 ()


  • Air-conduction hearing aid, behind-the-ear
KOVA-TROL I High Abnormal with urobillinogen (8x60mL) Quest
KOVA INTERNATIONAL, INC.
87533Q
In Commercial Distribution

  • 00855617006415 ()
87533Q

  • Urine sediment IVD, control
KOVA-Trol I: High Abnormal with urobilinogen (8x60 mL)
KOVA INTERNATIONAL, INC.
87533E
In Commercial Distribution

  • 00855617006330 ()
87533E

  • Urine sediment IVD, control
KOVA-Trol I: High Abnormal without urobilinogen (8x60 mL)
KOVA INTERNATIONAL, INC.
87426E
In Commercial Distribution

  • 00855617006309 ()
87426E

  • Urine sediment IVD, control
KOVA-Trol I: High Abnormal w/ urobilinogen (4x15 mL)
KOVA INTERNATIONAL, INC.
87334E
In Commercial Distribution

  • 00855617006255 ()
87334E

  • Urine sediment IVD, control
KOVA-Trol I: High Abnormal w/ urobilinogen (4x60 mL)
KOVA INTERNATIONAL, INC.
87332E
In Commercial Distribution

  • 00855617006231 ()
87332E

  • Urine sediment IVD, control
VALVE 42822 DELTA REG PRESS LEVEL I IMP
MEDTRONIC PS MEDICAL, INC.
42822
In Commercial Distribution

  • 00643169466869 ()

  • Performance Level 1.0


  • Cerebrospinal fluid shunt valve
MassCheck® Cortisol, Cortisone, Saliva Control Level I
Chromsystems Instruments + Chemicals GmbH
0353
In Commercial Distribution

  • 04250317552402 ()
  • 04250317552396 ()

  • 5 x 1ml
0353

  • Multiple steroid hormone IVD, control
Plasma Control Level I, Antibiotics in serum/plasma
Chromsystems Instruments + Chemicals GmbH
0183
In Commercial Distribution

  • 04250317541802 ()
  • 04250317546852 ()

  • 5 x 1ml
0183

  • Multiple-therapy therapeutic drug monitoring IVD, control
MassCheck® Free Metanephrines, Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0384
In Commercial Distribution

  • 04250317539519 ()
  • 04250317546715 ()

  • 5 x 3ml
0384

  • Multiple biogenic amine neurotransmitter IVD, control
MassCheck® total Metanephrines, Urine Control Level I
Chromsystems Instruments + Chemicals GmbH
0376
In Commercial Distribution

  • 04250317538949 ()
  • 04250317546524 ()

  • 5 x 2ml
0376

  • Multiple biogenic amine neurotransmitter IVD, control
MassCheck® Methylmalonic Acid Urine Control Level I
Chromsystems Instruments + Chemicals GmbH
0317
In Commercial Distribution

  • 04250317526007 ()
  • 04250317546500 ()

  • 5 x 2ml
0317

  • Methylmalonic acid (MMA) IVD, control
MassCheck® Methylmalonic Acid Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0314
In Commercial Distribution

  • 04250317525987 ()
  • 04250317546487 ()

  • 5 x 1ml
0314

  • Methylmalonic acid (MMA) IVD, control
MassCheck® Antiarrhythmic Drugs, Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0265
In Commercial Distribution

  • 04250317526625 ()
  • 04250317545558 ()

  • 5 x 1ml
0265

  • Multiple-therapy therapeutic drug monitoring IVD, control
MassCheck® Anti-HIV Drugs, Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0262
In Commercial Distribution

  • 04250317526304 ()
  • 04250317545459 ()

  • 5 x 1ml
0262

  • Multiple-therapy therapeutic drug monitoring IVD, control
MassCheck® Benzodiazepines 2, Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0241
In Commercial Distribution

  • 04250317524201 ()
  • 04250317545282 ()

  • 5 x 1ml
0241

  • Benzodiazepine group IVD, control
MassCheck® Benzodiazepines 1, Plasma Control Level I
Chromsystems Instruments + Chemicals GmbH
0238
In Commercial Distribution

  • 04250317524140 ()
  • 04250317545268 ()

  • 5 x 1ml
0238

  • Benzodiazepine group IVD, control
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