Genesisbps LLC
Mahwah, NJ, US
GENESISBPS LLC appears in FDA device records in Mahwah, NJ. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Genesisbps LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Genesis Bps, LLC510(k), enforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Genesisbps LLC in 2009.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2248588 | 1000527169 | GENESISBPS LLC | 400 Corporate Dr, Mahwah, NJ 07430 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2669-2014 | Pedi-Pak Pedi-Syringe Filter 35 mL Monoject 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 cryoprecipitate for pediatric and or neonatal transfusion. | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. | Class II | Terminated | |
| Z-2668-2014 | Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject 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 cryoprecipitate for pediatric and or neonatal transfusion | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. | Class II | Terminated | |
| Z-2667-2014 | 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 cryoprecipitate for pediatric and or neonatal transfusion | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain