Data / Medical devices / United States / Biosafe Supplies, LLC
Biosafe Supplies, LLC: FDA-registered device maker in Orlando, FL, United States, 2 510(k) clearances
Biosafe Supplies, LLC is registered with the FDA (registration 3014654360) in Orlando, FL, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 28, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014654360
- Address
- 230 Sunport Ln Ste 100, Orlando, FL, United States, 32809
- Owner or operator
- BioSafe Supplies, LLC (10058583)
- Roles
- Repackager or relabeler
- First device listed
- July 19, 2021
- Registered through
- 2026
- Brand names listed
- Alcohol Pads, COVID-19 Test, Gauze, HPV FLOQSwab for HPV Self Collection Kit, Micro-Pipette, Non-Sterile Specimen Storage, Single-Use Needle, Specimen Transport Vial and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| March 29, 1996 | K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Micro Pipette
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Pad, Alcohol, Device Disinfectant
Updated October 28, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.