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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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ASSY-LP CR PLUS,SEMI,SIGNS OF CIRCULATION
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000004

  • Rechargeable public semi-automated external defibrillator
ASSY-LP CR PLUS, AUTO,BREATHING
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000003

  • Rechargeable public automated external defibrillator
ASSY-LP CR PLUS,SEMI,CHECK FOR BREATHING
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000006

  • Rechargeable public semi-automated external defibrillator
ASSY-LP CR PLUS, AUTO,PULSE
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000002

  • Rechargeable public automated external defibrillator
ASSY-LP CR PLUS,SEMI,CHECK FOR PULSE
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000001

  • Rechargeable public semi-automated external defibrillator
ASSY-LPCR PLUS,AUTO,ENGLISH,AHA2005, FDA
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000157

  • Rechargeable public automated external defibrillator
ASSY-LPCR PLUS,SEMI,ENGLISH,AHA2005, FDA
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000156

  • Rechargeable public semi-automated external defibrillator
USED LP1000 CONFIG UNIT1000AAAABAAACBBAAAAAAAAA
PHYSIO-CONTROL, INC.
99425
In Commercial Distribution

  • 00883873778876 ()
99425-000025U

  • Non-rechargeable professional semi-automated external defibrillator
Indications for FH: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution

  • 04987671040374 ()


  • Apheresis system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-007
In Commercial Distribution

  • 00855728005192 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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