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510(k) Data Aggregation
K Number
K090917Device Name
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer
BAXA CORP.
Date Cleared
2010-02-19
(324 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.
Device Description
Not Found
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K Number
K070163Device Name
SWABBABLE CAP, MODEL 60205
Manufacturer
BAXA CORP.
Date Cleared
2007-08-03
(198 days)
Product Code
ODI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
Device Description
Provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure.
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K Number
K062909Device Name
REPEATER PUMP II TUBE SETS
Manufacturer
BAXA CORP.
Date Cleared
2007-03-09
(163 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
Device Description
The Repeater Pump II tube set provides the fluid pathway, pump cavity, valving, and tube set for the Repeater Pump II system. The tube set and pump platform work together to provide sterile transfer and reconstitution of pharmaceutical liquids. The tube set utilizes a plastic piston to mechanically pump required amounts of fluid from 0.2mL to 10mL with each piston stroke. A plastic pump core works in conjunction with the piston to provide appropriate fluid pathways for the draw and discharge strokes. There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.
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K Number
K022523Device Name
RAPID-FILL TUBESET, MODEL 90005
Manufacturer
BAXA CORP.
Date Cleared
2002-08-12
(13 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.
Device Description
The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.
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K Number
K002705Device Name
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Manufacturer
BAXA CORP.
Date Cleared
2001-03-28
(210 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983321Device Name
MICROFUSE DUAL RATE INFUSER
Manufacturer
BAXA CORP.
Date Cleared
1998-10-06
(14 days)
Product Code
FRN, RDN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BAXA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.
Device Description
The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.
The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.
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