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510(k) Data Aggregation
K Number
K230992Device Name
DJF Intravascular Administration Set
Manufacturer
Date Cleared
2023-06-09
(64 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Wei De Li Trade Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DJF Intravascular Administration Sets are intended for use with Curlin (Moog) Infusion Pump, for the delivery of fluids from a container or bag to the patient's vascular system
Device Description
DJF Administration Sets are sterile/non-pyrogenic, single use, non-DEHP PVC tubing with a Universal Spike, Slide Clamp, Luer Lock (male) with integral anti-free flow valve (AFF) {optional, separately provided}, 0.2 micron or 1.2 micron filters, Yellow Cassette and Blue key (locator pin) for use with the Curlin IV pump. Three (3) new sets are: 1. DJFCUR001: Administration set compatible with Curlin Pump 2. DJFCUR002: Administration set with 0.2 micron filter compatible with Curlin Pump 3. DJFCUR003: Administration set with 1.2 micron filter compatible with Curlin Pump
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