AMERICAN I.V. PRODUCTS, INC.

FDA Device Registration & Listing · HARMANS, MD, US · Registration 1121996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1121996
FEI Number
1121996
Entity Name
AMERICAN I.V. PRODUCTS, INC.
City/State/Country
HARMANS, MD, US
Establishment Address
7485 SHIPLEY AVE., HARMANS, MD 21077, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AMERICAN I.V. PRODUCTS, INC. (Owner Number: 1121996)
Owner / Operator Contact Address
7485 SHIPLEY AVE., --, Harmans, MD 21077, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142333
PMA Number
N/A

All Registered Proprietary Names

BC10747 Patient Pendant Bolus Cable BC10925 Patient Pendant Bolus Cable AIV Fetal Transducer AIV Fetal Transducer Smart Label, Propofol BX12812 - Smart Label, Propofol

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2012-06-28
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2007-12-12
HFM Monitor, Uterine Contraction, External (For Use In Clinic) Obstetrics/Gynecology Class 2 884.2720 2007-12-12
HGL Transducer, Ultrasonic, Obstetric Obstetrics/Gynecology Class 2 884.2960 2007-12-12
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2014-12-18

Official Correspondent

Melinda Leishear

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN I.V. PRODUCTS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K771196 Hewlett-Packard Co. MARKER GENERATOR MODULES - 21597A 1977-08-03
K813458 Cranbury Medical Labs, Inc. FETASCAN 1000, 1000A OBSTETRICAL DATA 1982-01-28
K100420 Philips Medizin Systeme Boeblingen GmbH PHILIPS OBTRACEVUE MODEL SW REV. G.00 2010-07-26
K173941 Philips Medizin Systeme Boeblingen GmbH IntelliSpace Perinatal Rev.K.00 2018-09-10
K062137 Philips Medizin Systeme Boeblingen GmbH MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 2006-08-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-06 N/A 2
FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06 N/A 2
FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1121996. Last updated year: 2026. Please use registration number 1121996 when referencing this establishment in official correspondence.
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