Data / Medical devices / United States / Generica Medical International
Generica Medical International: FDA-registered device maker in La Verne, CA, United States, 2 510(k) clearances
Generica Medical International is registered with the FDA (registration 3010331226) in La Verne, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 11, 2018. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010331226
- Address
- 1910 D ST, La Verne, CA, United States, 91750
- Owner or operator
- Generica Medical International (10044483)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- September 12, 2014
- Registered through
- 2027
- Brand names listed
- Generica Medical 60ml Enteral Syringe With Enfit & Transitional Adapter, Generica Medical Cross Spike Plus, Generica Medical Cross Spike Plus with ENFit, Generica Medical Enteral Delivery Gravity Bag Set, Generica Medical Enteral Delivery Gravity Bag Set with ENFit, Generica Medical Enteral Delivery Pump Bag Set, Generica Medical Enteral Delivery Pump Bag Set with ENFit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tube, Feeding | FPD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 11, 2018 | K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | PNR | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 28, 2014 | K133077 | GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET | KNT | Substantially Equivalent | Generica Medical International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Feeding
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Enteral Syringes With Enteral Specific Connectors
Updated October 11, 2018. 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.