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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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AMY (Amylase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-227
In Commercial Distribution

  • 00817302020298 ()

  • Kit contains 3 R1 bottles and 1 package insert
  • Total Volume: 20 Milliliter
AU-227

  • Amylase isoenzyme IVD, kit, spectrophotometry
Blood Culture Collection Kit, Baptist Medical Center South Only
AERO-MED, LLC
CA15850
Not in Commercial Distribution

  • 50885380164130 ()
  • 10885380164132 ()
CA15850

  • Phlebotomy kit
Precision Flow Oxygen Assist Module, Nellcor UKIT South Africa
VAPOTHERM, INC.
OAM-NEL-UKIT-ZA
In Commercial Distribution

  • 00841737104315 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, Masimo UKIT South Africa
VAPOTHERM, INC.
OAM-MAS-UKIT-ZA
In Commercial Distribution

  • 00841737104308 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
MTS L/H KIT 1 -SOUTH AUSTIN HOSP PG
MEDLINE INDUSTRIES, INC.
60183292
In Commercial Distribution

  • 20193489050025 ()
  • 10193489050028 ()
60183292

  • Angiography kit
Personal Use Kit OC-Auto, for KPS South bay (HBRCTY)
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS SB
In Commercial Distribution

  • 00816917020402 ()


  • Faecal occult blood IVD, reagent
SINGLE LINE KIT WITH 03ML DEVICE FOR SOUTH SHORE HOSP
ICU MEDICAL, INC.
46099-05
In Commercial Distribution

  • 10840619045279 ()
  • 00840619045272 ()
46099-05

  • In-line arterial blood sampling set
Personal Use Kit OC-Auto, Custom Kit for CPL South East
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-CPLSE
In Commercial Distribution

  • 00816917023090 ()


  • Faecal occult blood IVD, reagent
Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CY010, 5mmX35cm EPIX® LAPA DISSECT, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2656
In Commercial Distribution

  • 30607915133529 ()


  • Rigid endoscopic grasping forceps, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
1st Tier 6mm x 31G pen needles
OWEN MUMFORD USA INCORPORATED
AN 3590SPW
In Commercial Distribution

  • 00761059591856 ()
  • 00761059590859 ()
  • 00761059592853 ()
  • 00384703590007 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
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