Data / Medical devices / United States / American I.V. Products, Inc.
American I.V. Products, Inc.: FDA-registered device maker in Harmans, MD, United States, 5 510(k) clearances
American I.V. Products, Inc. is registered with the FDA (registration 1121996) in Harmans, MD, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 18, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1121996
- Address
- 7485 Shipley Ave., Harmans, MD, United States, 21077
- Owner or operator
- AMERICAN I.V. PRODUCTS, INC. (1121996)
- Roles
- Manufacturer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- AIV Fetal Transducer, BC10747 Patient Pendant Bolus Cable, BC10925 Patient Pendant Bolus Cable, BX10468 Assembly Door P2 Baxter 6201/6301 F049120021, BX10469 Assembly Door 1 Baxter F059120016, BX12812 - Smart Label, Propofol, Pediatric Drain and Tube Management System (PeDaT), Smart Label, Propofol
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Obstetric | HGL | 2 | 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 |
|---|---|---|---|---|---|---|
| December 18, 2014 | K142333 | SMART LABEL, PROPOFOL | MRZ | Substantially Equivalent | American I.V. Products, Inc. Dba Aiv, Inc. | accessdata.fda.gov |
| April 12, 2012 | K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | MRZ | Substantially Equivalent | American I.V. Products, Inc. | accessdata.fda.gov |
| September 14, 2004 | K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | HFM | Substantially Equivalent | American I.V. Products, Inc. | accessdata.fda.gov |
| August 16, 2004 | K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 | HGM | Substantially Equivalent | American I.V. Products, Inc. | accessdata.fda.gov |
| October 9, 2003 | K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 | FRN | Substantially Equivalent | American I.V. Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Uterine Contraction, External (For Use In Clinic)
- All makers of Transducer, Ultrasonic, Obstetric
- All makers of Holder, Ureteral Catheter
- All makers of Pump, Infusion
- All makers of System, Monitoring, Perinatal
- All makers of Accessories, Pump, Infusion
Updated December 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.