FDA.reportPublic FDA data

Unipower

Primary DI
00817392025654
Brand
Unipower
Company
UNIPOWER CORPORATION
Model
B11614
Published
2024-02-13
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
00817392025654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817392025654008173920256548173920256540817392025654

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

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
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
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
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