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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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KC 042-5P - 42" length, 15mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 042-5P
In Commercial Distribution

  • M996KC0425P0 ()


  • Ventilator breathing circuit, single-use
KC 042-5N - 42" length, 10mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 042-5N
In Commercial Distribution

  • M996KC0425N0 ()


  • Ventilator breathing circuit, single-use
KC 042-5 - 42" length, 22mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 042-5
In Commercial Distribution

  • M996KC04250 ()


  • Ventilator breathing circuit, single-use
KC 040-5P - 40" length, 15mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 040-5P
In Commercial Distribution

  • M996KC0405P0 ()


  • Ventilator breathing circuit, single-use
No Description
SOMNETICS INTERNATIONAL, INC.
Water Reservoir
In Commercial Distribution

  • M9505030800 ()
503080

  • Heated respiratory humidifier
Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by securing ventilator circuit components.
INSTRUMENTATION INDUSTRIES, INCORPORATED
NP 105-1
In Commercial Distribution

  • M996NP10510 ()
  • M996NP10512 ()
  • M996NP10515 ()
NP 105-1

  • Ventilator breathing circuit, single-use
KC 060-5N - 60" length, 10mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 060-5N
In Commercial Distribution

  • M996KC0605N0 ()


  • Ventilator breathing circuit, single-use
KC 040-5N - 40" length, 10mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 040-5N
In Commercial Distribution

  • M996KC0405N0 ()


  • Ventilator breathing circuit, single-use
KC 040-5 - 40" length, 22mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 040-5
In Commercial Distribution

  • M996KC04050 ()


  • Ventilator breathing circuit, single-use
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
AL-1400.V005
In Commercial Distribution

  • M485AL1400V0052 ()
  • M485AL1400V0051 ()


  • Ventilator breathing circuit, single-use
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
AL-1100.V002
In Commercial Distribution

  • M485AL1100V0022 ()
  • M485AL1100V0021 ()


  • Ventilator breathing circuit, single-use
CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution

  • 03610522260829 ()

  • 1 ea
12016687

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution

  • 03610522203437 ()

  • 1 each
12014335

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 96 Dx
BIO-RAD LABORATORIES, INC.
12014330
In Commercial Distribution

  • 03610522203413 ()

  • 1 each
12014330

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1844095-IVD
In Commercial Distribution

  • 03610520550984 ()
1844095-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1845097-IVD
In Commercial Distribution

  • 03610520457818 ()
1845097-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
ELITECHGROUP SPA
INT030-K
In Commercial Distribution

  • 03661540900006 ()
INT030-K

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
NXSTAGE MEDICAL, INC.
FW-301-A
In Commercial Distribution

  • M535FW301A0 ()


  • Conduction blood/fluid warmer
No Description
NXSTAGE MEDICAL, INC.
FW-301-1
In Commercial Distribution

  • M535FW30110 ()


  • Conduction blood/fluid warmer
No Description
NXSTAGE MEDICAL, INC.
FW-301
In Commercial Distribution

  • M535FW3010 ()


  • Conduction blood/fluid warmer
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