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The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.

The Bolus Accessory may connect to any positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed.

The provided document describes the I-Flow Bolus Accessory Set, a mechanical device intended to deliver fixed boluses of medication. The primary focus of the document is on the specifications and equivalence to previously marketed devices (510(k) submission).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.

The Bolus Accessory may connect to any Paragon administration set to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed. The Bolus Accessory is available in 0.5 ml bolus volume. The Bolus Accessory is a mechanical device that requires no external power.

Here's a breakdown of the acceptance criteria and study information for the Paragon Bolus Accessory Set, based on the provided document:

Acceptance Criteria and Device Performance

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