Data / Medical devices / United States / Genesisbps LLC
Genesisbps LLC: FDA-registered device maker in Mahwah, NJ, United States, 1 510(k) clearance
Genesisbps LLC is registered with the FDA (registration 2248588) in Mahwah, NJ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2248588
- FEI number
- 1000527169
- Address
- 400 Corporate Dr, Mahwah, NJ, United States, 07430
- Owner or operator
- GENESISBPS LLC (9020509)
- Roles
- Specification developer
- First device listed
- October 24, 2000
- Registered through
- 2026
- Brand names listed
- FLU-ADMIN I.V. Sets, GENESIS RAPIDWELD STW, Genesis RapidWeld II STW, model GRW-430-02, Genesis Tube Stripper, Total Containment Device (TCD)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Blood Mixing And Blood Weighing | KSQ | 1 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 13, 2009 | K082027 | FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 | FPA | Substantially Equivalent | Genesis Bps, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 17, 2014 | 68874 | Class II | Terminated | Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipit | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Blood Mixing And Blood Weighing
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Set, Administration, Intravascular
Updated September 18, 2014. 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.