Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015192982

FEI Number

3015192982

Entity Name

MERRIMACK MANUFACTURING

City/State/Country

Manchester, NH, US

Establishment Address

540 North Commercial Ave, STE 110, Manchester, NH 03101, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Merrimack Manufacturing (Owner Number: 10062587)

Owner / Operator Contact Address

540 North Commercial Ave, STE 110, Manchester, NH 03101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

twiist Loop Powered by Tidepool; twiist Loop twiist Automated Insulin Delivery (AID) System Powered by Tidepool; Twiist AID System DEKA Arm System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2026-03-04
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2025-02-21
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2025-02-21
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-02-21
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2026-03-02
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	General Hospital	Class 2	880.5725	2026-03-02
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2026-03-02
PAE	Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography	Physical Medicine	Class 2	890.3450	2022-10-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-04-20

Official Correspondent

Priya Sampath

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Merrimack Manufacturing

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044561902	Merrimack Manufacturing	Manchester, NH, US

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
3014197758	FEDEX SUPPLY CHAIN, INC.	Olive Branch, MS, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US
3019004087	BETA BIONICS, INC.	Irvine, CA, US
3016798778	MILLYARD ADVANCED MEDICAL PRODUCTS LLC	Manchester, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015192982. Last updated year: 2026. Please use registration number 3015192982 when referencing this establishment in official correspondence.