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510(k) Data Aggregation
K Number
K023890Device Name
PREPARE CARTRIDGE
Manufacturer
Date Cleared
2003-02-07
(78 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
APPRO HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets.
For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration
Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.
Device Description
Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site.
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K Number
K023769Device Name
PREPARE ADMINISTRATION SET
Manufacturer
Date Cleared
2002-12-30
(48 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
APPRO HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prepare™ Administration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration.
Prepare™ Administration Set is indicated for use in acute and alternate site settings. Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.
Device Description
Prepare™ Administration Set is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides the interface with the pump and a sterile fluid path from an infusion fluid container to a patient's access catheter.
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