Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183890

FEI Number

2183890

Entity Name

UNIPOWER CORP.

City/State/Country

Minnetonka, MN, US

Establishment Address

6024 Culligan Way, Minnetonka, MN 55345, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSI Batteries (Owner Number: 10087947)

Owner / Operator Contact Address

6024 Culligan Way, Minnetonka, MN 55345, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Unipower Unipower Unipower Unipower Unipower

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2023-05-04
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2023-05-04
DRK	Dc-Defibrillator, High Energy, (Including Paddles)	Cardiovascular	Class 3	870.5300	2023-05-04
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2023-05-04
FCP	Box, Battery, Pocket	Gastroenterology, Urology	Class 1	876.1500	2023-05-04
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2023-05-04

Official Correspondent

Colt Oldenburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSI Batteries

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
K203231	Philips North America, LLC	Switched Internal Paddles	2021-01-11
K200849	Remote Diagnostic Technologies, Ltd. A Philips Company	Tempus LS - Manual	2020-07-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0557-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Z-0564-2021	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Z-0861-2022	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Z-1825-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Z-2028-2024	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

Similar Registrations

Registration Number	Establishment Name	Location
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN
9614485	NDD MEDIZINTECHNIK AG	ZURICH, CH
9710567	Besmed Health Business Corporation	New Taipei City, TW
3012309966	ENGLERT GMBH & CO. KG	Wertheim Baden-Wurttemberg, DE
3010370454	SENSATRONIC GMBH	Wismar Mecklenburg-Western Pomerania, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183890. Last updated year: 2026. Please use registration number 2183890 when referencing this establishment in official correspondence.