Search Results
Found 1 results
510(k) Data Aggregation
K Number
K070529Device Name
AFF (MARK I) VOLUMETRIC INFUSION PUMP
Manufacturer
Date Cleared
2007-05-08
(74 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
Device Description
The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump is a medical device used to pump fluids into a patient in a controlled manner. It is suitable for delivering a wide range of infusions, including medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia) operating modes. It is also compatible with the majority of IV procedures and most standard IV sets.
Ask a Question
Ask a specific question about this device
Page 1 of 1