Elite Biomedical Solutions 10013795 EBS

GUDID 00860008635402

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.

Elite Biomedical Solutions LLC

Infusion pump remote control

• Primary Device ID: 00860008635402
• NIH Device Record Key: 27352800-d152-494d-80c9-edb6bd2de0bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Biomedical Solutions
• Version Model Number: B
• Catalog Number: 10013795 EBS
• Company DUNS: 078500323
• Company Name: Elite Biomedical Solutions LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com
• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com
• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com
• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com
• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com
• Phone: 855-291-6701
• Email: bcompliment@elitebiomedicalsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008635402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220695

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12