Data / Medical devices / United States / Charter Medical, LLC
Charter Medical, LLC: FDA-registered device maker in Winston Salem, NC, United States, 2 510(k) clearances
Charter Medical, LLC is registered with the FDA (registration 1066733) in Winston Salem, NC, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 15, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1066733
- FEI number
- 3002910717
- Address
- 3948-A West Point BLVD., Winston Salem, NC, United States, 27103
- Owner or operator
- CHARTER MEDICAL, LLC. (2246665)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 16, 2007
- Registered through
- 2026
- Brand names listed
- Advect Fluid Transfer Set, Blood Transfer Bag, Blood Transfer Set, Cell Freeze Cryogenic Storage Container, EXP-Pak¿ Cell Expansion Bio-Containers, Neonatal Syringe Set, Tru-Flo Neo-40 Syringe Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Contract manufacturer | accessdata.fda.gov |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | 2 | Manufacturer | accessdata.fda.gov |
| Container, Frozen Donor Tissue Storage | LPZ | U | Manufacturer | accessdata.fda.gov |
| Microfilter, Blood Transfusion | CAK | 2 | Manufacturer | accessdata.fda.gov |
| Set, Blood Transfusion | BRZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| System, Suspension, Cell Culture | KJF | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 15, 2000 | K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | BRZ | Substantially Equivalent | Charter Medical, Ltd. | accessdata.fda.gov |
| August 30, 1999 | K990310 | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | CAK | Substantially Equivalent | Charter Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Microfilter, Blood Transfusion
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Container, Frozen Donor Tissue Storage
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of System, Suspension, Cell Culture
- All makers of Container, Empty, For Collection & Processing Of Blood & Blood Components
Updated August 15, 2000. 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.