Healeon HD PRP

GUDID 10850034511310

A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.

Bimini Technologies LLC

Haematological concentrate system
Primary Device ID10850034511310
NIH Device Record Key3bd2a85d-75ab-478d-9449-3a3dccdba03d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealeon HD PRP
Version Model NumberHDPRP15
Company DUNS076649467
Company NameBimini Technologies LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511313 [Primary]
GS110850034511310 [Package]
Contains: 00850034511313
Package: Box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-25
Device Publish Date2022-02-17

On-Brand Devices [Healeon HD PRP]

00850034511405A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo
10850034511310A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo

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