Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016798778

FEI Number

3016798778

Entity Name

MILLYARD ADVANCED MEDICAL PRODUCTS LLC

City/State/Country

Manchester, NH, US

Establishment Address

540 Commercial Street, Suite 306, Manchester, NH 03101, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Millyard Advanced Medical Products LLC (Owner Number: 10072764)

Owner / Operator Contact Address

540 Commercial Street, Suite 306, Manchester, NH 03101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Remunity" Pump for Remodulin (treprostinil) Injection iiSure Infusion Set Remunity System Remunity Pump for Remodulin (treprostinil) Injection

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2025-02-26
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-02-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-02-26
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	General Hospital	Class 2	880.5725	2020-05-01
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-06-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-04-26
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	General Hospital	Class 2	880.5725	2025-02-26
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-02-26
PKU	Insulin Pump Secondary Display	Clinical Chemistry	Class 2	862.1350	2026-05-12

Official Correspondent

Jay Burkholder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Millyard Advanced Medical Products LLC

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
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

Registration Number	Establishment Name	Location
3006400278	Picis Clinical Solutions, S.A.U.	BARCELONA, ES
3010817588	MEDICAL DECISION NETWORK	Charlottesville, VA, US
3017986070	BIOINTELLISENSE INC.	Golden, CO, US
3025343017	COMERGE AG	Zurich, CH
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016798778. Last updated year: 2026. Please use registration number 3016798778 when referencing this establishment in official correspondence.