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510(k) Data Aggregation
K Number
K030739Device Name
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
Manufacturer
INFUSION DYNAMICS, INC.
Date Cleared
2004-01-14
(310 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
INFUSION DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ID Power Infuser® Model M100B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with Clinical Shock, hypovolemic shock, and septic shock. The device is intended for use by medical, paramedical, and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge (K992044), the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid fluids. The ID Power Infuser® Model M100B-3A is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is intended to deliver resuscitative fluids, whole blood and packed red blood cells. The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.
Device Description
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K Number
K992044Device Name
INFUSION DYNAMICS POWER INFUSER MODEL M100B
Manufacturer
INFUSION DYNAMICS, INC.
Date Cleared
1999-09-08
(83 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
INFUSION DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.
The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.
The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.
Device Description
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K Number
K974074Device Name
INFUSION DYNAMICS POWER INFUSER
Manufacturer
INFUSION DYNAMICS, INC.
Date Cleared
1998-02-17
(111 days)
Product Code
KZD
Regulation Number
880.5420Why did this record match?
Applicant Name (Manufacturer) :
INFUSION DYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.
The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.
The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.
Device Description
Not Found
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