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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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Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-053
In Commercial Distribution

  • 00884999042773 ()
06N38-053

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-033
In Commercial Distribution

  • 00884999042728 ()
06N38-033

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-020
In Commercial Distribution

  • 00884999025745 ()
06N38-020

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery unit, system-based
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400Z0
In Commercial Distribution

  • 08714729997481 ()
M004CRBS400Z0

  • Cardiac cryosurgical system
Evaluation Kit
BOSTON SCIENTIFIC CORPORATION
M004CRBS470D0
In Commercial Distribution

  • 08714729992752 ()
M004CRBS470D0

  • Cardiac cryosurgical system
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400R0
In Commercial Distribution

  • 08714729992721 ()
M004CRBS400R0

  • Cardiac cryosurgical system
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400H0
In Commercial Distribution

  • 08714729992714 ()
M004CRBS400H0

  • Cardiac cryosurgical system
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS4000
In Commercial Distribution

  • 08714729992691 ()
M004CRBS4000

  • Cardiac cryosurgical system
No Description
BIOTRONIK SE & Co. KG
433307
In Commercial Distribution

  • 04035479157838 ()
433307

  • Implantable electrical stimulation lead suture sleeve
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