FDA.reportPublic FDA data

Unipower

Primary DI
00817392026248
Brand
Unipower
Company
UNIPOWER CORPORATION
Model
B12305
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00817392026248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817392026248008173920262488173920262480817392026248

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817392026255UnipowerB123062026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026255UnipowerUNIPOWER CORPORATIONLDD2026-06-02
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
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