Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022978896

FEI Number

3022978896

Entity Name

Bimini Health Tech

City/State/Country

Plano, TX, US

Establishment Address

8400 Belleview Drive, Ste. 125, Plano, TX 75024, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Bimini Health Tech (Owner Number: 10048045)

Owner / Operator Contact Address

8400 Belleview Drive, Suite 125, Plano, TX 75024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200168

PMA Number

N/A

All Registered Proprietary Names

Puregraft 850 Puregraft 850 Twin Pack AutoPose Restore Dermapose Refresh Puregraft Vacuum Lid Puregraft Combined Adapter Vacuum Lid - Port Replacement Kit Vacuum Lid - O-Ring Kit Dermapose Refresh Stand DIRECT2 Lid, Drain Lever Replacement Kit DIRECT2 Lid, Drain Port Replacement Kit DIRECT2 Lid Puregraft SYNC Puregraft Instrument Set Puregraft 250 Healeon Duet Amplifine Adaptive Dermapose Access

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-07-14
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-07-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-08-08
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2026-02-17
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2017-05-30
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-07-14
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-04-30
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2020-06-15

Official Correspondent

Frankie Ng

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bimini Health Tech

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022978896. Last updated year: 2026. Please use registration number 3022978896 when referencing this establishment in official correspondence.