Data / Medical devices / United States / A-S Medication Solutions LLC
A-S Medication Solutions LLC: FDA-registered device maker in Libertyville, IL, United States, 15 510(k) clearances
A-S Medication Solutions LLC is registered with the FDA (registration 1450743) in Libertyville, IL, United States. It lists 12 device types. The FDA files 15 510(k) clearances under its listings, the newest dated April 13, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1450743
- Address
- 2401 Commerce Dr, Libertyville, IL, United States, 60048
- Owner or operator
- A-S Medication Solutions LLC (10086594)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- November 22, 2022
- Registered through
- 2027
- Brand names listed
- BAND-AID (FLEXIBLE FABRIC) BRAND ADHESIVE BANDAGES 10 XL BAND-AID, BD 1/2ml Syringe, BD Home Sharps Container, BD Insulin Syrg 27Gx5/8" 1ml, BD Insulin Syringe MicroFine Miscellaneous 28G X 1/2" 0.5 ML 28G X 1/2" 0.5 ML, BD Pen Needle Mini U/F Miscellaneous 31G X 5 MM 31G X 5 MM, BD SafetyGlide Insulin 1/2ml 29G X 1/2 (0.33mm x 13 mm), BD Veo Insulin Syringe U/F Miscellaneous 31G X 15/64" 0.3 ML 31G X 15/64" 0.3 ML and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 13, 2023 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| December 7, 2022 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| December 23, 2021 | K193407 | Contour® next GEN Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ascensia Diabetes Care | accessdata.fda.gov |
| June 12, 2020 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| October 21, 2019 | K190054 | BD Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 27, 2018 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | QBJ | Unknown | Dexcom, Inc. | accessdata.fda.gov |
| September 9, 2016 | K152879 | Sure-Fine Insulin Syringes | FMF | Substantially Equivalent | Shina Med Corporation | accessdata.fda.gov |
| July 26, 2012 | K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | LFR | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| July 13, 2012 | K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Infopia Co, Ltd. | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 3, 2008 | K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | MMK | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| January 9, 2003 | K024112 | BD INSULIN SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| September 16, 2002 | K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | MMK | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 28, 1994 | K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Pad, Menstrual, Unscented
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Updated April 13, 2023. 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.