Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005627859

FEI Number

3005627859

Entity Name

Sanmina

City/State/Country

Kunshan Jiangsu, CN

Establishment Address

312, Qing Yang South Road, Economic and Technical Development Zone, Kunshan Jiangsu 215300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sanmina Corporation (Owner Number: 2129538)

Owner / Operator Contact Address

13000 S. Memorial Pkwy, --, Huntsville, AL 35803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Omnipod Insulin Management System Lutrepulse Drug Delivery Device Omnipod DASH Insulin Management System Omnipod Insulin Management System Omnipod 5 Pod System, test, blood glucose, over the counter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2022-09-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-09-20
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2022-01-05
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-06-20
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-07-08
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2020-07-08
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2020-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Stahl Business: Sanmina Email: jeffrey.stahl@sanmina.com Phone: (256) 8824125

Related Public Records

Same Entity

Sanmina Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004139819	Sanmina Ireland UC	FERMOY, CORK Munster, IE
3004201275	SANMINA-SCI AB	SJALEVAD Vasternorrland, SE
3009609218	Sanmina Corporation	Carrollton, TX, US
3007867838	Sanmina	SAN JOSE, CA, US
3004016520	SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.	Maalot-Tarshiha Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082590	Lifescan, Inc.	SYMPHONY METER REMOTE	2008-12-17
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
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512
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.

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2029275	Sterigenics U.S., LLC	Corona, CA, US
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005627859. Last updated year: 2026. Please use registration number 3005627859 when referencing this establishment in official correspondence.