Elite Biomedical Solutions

Primary DI
00860008635402
Brand
Elite Biomedical Solutions
Company
Elite Biomedical Solutions LLC
Model
B
Catalog number
10013795 EBS
Device description
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.
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220695000Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions2022-04-29MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008635402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008635402008600086354028600086354020860008635402

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an infusion pump (e.g., analgesia infusion pump, insulin infusion pump) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-291-6701bcompliment@elitebiomedicalsolutions.com

Regulatory Flags#

DUNS number
078500323
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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