FDA.reportPublic FDA data

Unipower

Primary DI
00817392025289
Brand
Unipower
Company
UNIPOWER CORPORATION
Model
B12017
Published
2021-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940842000UNIPOWER RECHARGEABLE BATTERY PACKUnipower Corp.1994-09-07LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817392025289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817392025289008173920252898173920252890817392025289

GMDN Terms#

Term, Definition table
TermDefinition
Primary battery"A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in ""IEC 60086-1 Primary batteries - Part 1: General"", or the latest version of this standard."

Regulatory Flags#

DUNS number
609162797
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817392026217UnipowerB122432026-05-13
00817392026224UnipowerB122462026-05-13
00817392026231UnipowerB122562026-05-13
00817392026200UnipowerB122582025-04-15
00817392026187UnipowerB122522025-04-01
00817392026194UnipowerB122532025-04-01
00817392026170UnipowerB122262024-11-14
00817392025982UnipowerB120952024-07-26
00817392025999UnipowerB120882024-07-26
00817392026002UnipowerB120892024-07-26
00817392026019UnipowerB120902024-07-26
00817392026026UnipowerB120912024-07-26
00817392026033UnipowerB120922024-07-26
00817392026040UnipowerB120932024-07-26
00817392026057UnipowerB120942024-07-26
00817392026064UnipowerB120962024-07-26
00817392026071UnipowerB120972024-07-26
00817392026088UnipowerB120982024-07-26
00817392026095UnipowerB120992024-07-26
00817392026101UnipowerB121002024-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026217UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026224UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026231UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392025647UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025654UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025609UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
08054242441789NAFIAB SPALDD2020-04-12
08054242441796NAFIAB SPALDD2020-04-12
08054242441802NAFIAB SPALDD2020-04-12
08054242441819NAFIAB SPALDD2020-04-12
08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
08054242441871NAFIAB SPALDD2020-04-12
08054242441895NAFIAB SPALDD2020-04-12
08054242444933NAFIAB SPALDD2020-04-12
08054242446425NAFIAB SPALDD2020-04-12
08054242446432NAFIAB SPALDD2020-04-12
08054242446449NAFIAB SPALDD2020-04-12
08054242446456NAFIAB SPALDD2020-04-12
00009336009596Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPLDD2019-10-17