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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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The Epinephrine Convenience Kit contains two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device is a 3/10 mL syringe that has mL graduation marks with color zones that align with color zones that correspond to pediatric weight ranges that can be used as a secondary confirmation that measured volumes are within ranges that are common for a patient’s weight. The Kit is intended for use in clinical and emergency medical settings to assist healthcare professionals and emergency medical personnel in measuring a desired volume of epinephrine for delivery to pediatric patients.
CD Acquisitions, LLC
1
In Commercial Distribution

  • 00860012210800 ()
  • 00860012210817 ()
  • 10860012210814 ()

  • Total Volume: 0.3 Milliliter
  • Length: 0.5 Inch
  • Needle Gauge: 29 Gauge
CD-EPI-001-NV

  • General-purpose syringe/needle
MTR Manual Blood Pressure Cuff Blue - box of 24
Med-Tech Resource, LLC
MTR-BP100-BLU
In Commercial Distribution

  • 00860012184590 ()


  • Blood pressure cuff, reusable
DispenSecur is a device intended for medical purposes to provide alerts and controlled patient access to medication based on dosing schedules predetermined by a healthcare provider. The device may be used with either liquid or solid dosage forms of one medication type. The device is not intended to manage multiple medications.
Verinetics Inc
1
In Commercial Distribution

  • 00860011977513 ()


  • Personal pill dose dispenser, electric
Fully Automatic Bio-chemistry Analyser
STERILE SAFEQUIP & CHEMICALS LLP
33.ZCH01
In Commercial Distribution

  • 00860011967750 ()
ZCH03

  • Multiple clinical chemistry analyser IVD, laboratory
Semi Automatic Bio-chemistry analyser
STERILE SAFEQUIP & CHEMICALS LLP
31.ZCH01
In Commercial Distribution

  • 00860011967743 ()
ZCH01

  • Multiple clinical chemistry analyser IVD, laboratory
The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
REDDROP DX, INC.
300-25-007
In Commercial Distribution

  • 00860011954002 ()
  • 00860011954033 ()
  • 00860011954026 ()
  • 00860011954019 ()


  • Manual blood lancing device, single-use
Single Use, Laparoscopic Metzenbaum Scissor, 5mm tip, 330mm/13" L
SBH Surgical
Single Use
In Commercial Distribution

  • 00860011953401 ()
SBH-1000-34

  • Electrosurgical handpiece/electrode holder, single-use
No Description
LOOCID LLC
UNI-BB-37
In Commercial Distribution

  • 00860011925996 ()

  • Outer Diameter: 3.7 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-35-R
In Commercial Distribution

  • 80860011925978 ()
  • 00860011925989 ()


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-35
In Commercial Distribution

  • 00860011925972 ()

  • Outer Diameter: 3.5 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-30-R
In Commercial Distribution

  • 80860011925954 ()
  • 00860011925965 ()


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-30
In Commercial Distribution

  • 00860011925958 ()

  • Outer Diameter: 3.0 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-20-R
In Commercial Distribution

  • 80860011925930 ()
  • 00860011925941 ()


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-20
In Commercial Distribution

  • 00860011925934 ()

  • Outer Diameter: 2.0 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-42-R
In Commercial Distribution

  • 80850055961933 ()
  • 00860011925927 ()

  • Outer Diameter: 4.2 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-40-R
In Commercial Distribution

  • 80850055961971 ()
  • 00860011925910 ()

  • Outer Diameter: 4.0 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-32-R
In Commercial Distribution

  • 80850055961926 ()
  • 00860011925903 ()

  • Outer Diameter: 3.2 Millimeter


  • Fluted surgical drill bit, reusable
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software
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