Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014654360

FEI Number

3014654360

Entity Name

BIOSAFE SUPPLIES, LLC

City/State/Country

Orlando, FL, US

Establishment Address

230 Sunport Ln Ste 100, Orlando, FL 32809, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BioSafe Supplies, LLC (Owner Number: 10058583)

Owner / Operator Contact Address

9436 Southridge Park Court, Suite 400, Suite 400, Orlando, FL 32819, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK050036

PMA Number

N/A

All Registered Proprietary Names

Temp Control Mailer Non-Sterile Specimen Storage HPV FLOQSwab for HPV Self Collection Kit COVID-19 Test Alcohol Pads Gauze Single-Use Needle Transport Vial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNL	Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	Pathology	Class 1	864.3250	2021-07-21
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-07-21
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2021-07-29
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-08-30
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2021-07-21
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2021-07-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-07-20

Official Correspondent

Nadine Monico

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioSafe Supplies, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

Registration Number	Establishment Name	Location
3023443877	Thermo Fisher Scientific (Monterrey)	Apodaca Nuevo Leon, MX
1314344	Nalge Nunc International Corporation	Rochester, NY, US
3043606682	SIPCON TECHNOLOGIES PRIVATE LIMITED	Ambala Haryana, IN
3009134624	CSafe Global	Dayton, OH, US
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014654360. Last updated year: 2026. Please use registration number 3014654360 when referencing this establishment in official correspondence.