Elite Biomedical Solutions LLC

Address:756 CINCINNATI BATAVIA PIKE STE C,Cincinnati,OH,45245,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessories, Pump, Infusion (MRZ) (1)

Premarket Exempt

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Elite Biomedical Solutions - 00860008635402 Catalog Number : 10013795 EBS

Device Description : Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps.The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.

Device Class : 2

Duns Number: 078500323

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

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