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510(k) Data Aggregation
K Number
K093332Device Name
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
Manufacturer
DELPHI MEDICAL SYSTEMS
Date Cleared
2009-12-09
(44 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
DELPHI MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delphi Infusion Pump is intended for use in the controlled delivery of epidural and IV solutions.
Device Description
The Delphi Infusion Pump is a large volume infusion pump customizable to meet the specific needs of multiple care areas and deliver a wide range of therapies in a safe and effective manner. For each area of care, clinically appropriate alarms, alerts, and performance specifications can be established. With the available Safety Suite, the pharmacy can define default and safe operating ranges for all drugs being infused. There are four basic infusion modes available plus epidural delivery. The Delphi Infusion Pump uses a rotary peristaltic pumping mechanism with dedicated disposable administration sets. Each administration set includes a precision-molded cassette designed for fast, safe, and secure single-handed pump loading. A safety slider switch on the cassette, along with a roller clamp, provides redundant free-flow protection when the tubing is unloaded. The user interface was designed using extensive input from clinical and human factors experts to offer a unique combination of a large touch screen display and a keypad for alpha-numeric data entries. The pump is designed for use on AC power with battery backup during power failure and is available during patient ambulation and transport. The portable light weight single-channel design allows for a dedicated display ("one screen, one drug") and improved utilization and increased flexibility in device placement.
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K Number
K073242Device Name
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
Manufacturer
DELPHI MEDICAL SYSTEMS
Date Cleared
2008-01-03
(45 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
DELPHI MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or travel environments.
The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.
Device Description
The Delphi Portable Oxygen Concentrator is lightweight and can deliver ≥ 87% oxygen to a patient through a standard single-lumen nasal cannula. The device detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period.
The device can be set to deliver flowrates between 1-5 LPM with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.
The Delphi Portable Oxygen Concentrator (POC) uses Pressure Swing Adsorption technology to deliver concentrated oxygen. A series of chambers and valves allows pressurized air to enter the sieve bed assembly, effectively separating nitrogen from the air. When one chamber is receiving pressurized air, the other is purging nitrogen back into the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in a chamber to be delivered to a patient when the device detects a patient breath.
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