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 Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control Infusion pump remote control
Primary Device ID00860008635402
NIH Device Record Key27352800-d152-494d-80c9-edb6bd2de0bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite Biomedical Solutions
Version Model NumberB
Catalog Number10013795 EBS
Company DUNS078500323
Company NameElite Biomedical Solutions LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com
Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com
Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com
Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com
Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com
Phone855-291-6701
Emailbcompliment@elitebiomedicalsolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008635402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-20
Device Publish Date2022-05-12

Trademark Results [Elite Biomedical Solutions]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELITE BIOMEDICAL SOLUTIONS
ELITE BIOMEDICAL SOLUTIONS
90192667 not registered Live/Pending
Elite Biomedical Solutions, LLC
2020-09-18
ELITE BIOMEDICAL SOLUTIONS
ELITE BIOMEDICAL SOLUTIONS
86528367 4830543 Live/Registered
Elite Biomedical Solutions, LLC
2015-02-09
ELITE BIOMEDICAL SOLUTIONS
ELITE BIOMEDICAL SOLUTIONS
86528278 4826063 Live/Registered
Elite Biomedical Solutions, LLC
2015-02-09

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