FDA.reportPublic FDA data

Unipower

Primary DI
00817392024145
Brand
Unipower
Company
UNIPOWER CORPORATION
Model
B11552
Published
2016-09-15
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817392024145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817392024145008173920241458173920241450817392024145

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container 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 is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
00817392026118UnipowerB121012024-07-26
00817392026125UnipowerB121022024-07-26
00817392026132UnipowerB121032024-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510D100ADVANCED MONITOR DEFIBRILLATORADVANCED INSTRUMENTATIONS, INC.LDD2026-01-14
00817392026200UnipowerUNIPOWER CORPORATIONLDD2025-04-15
00817392026187UnipowerUNIPOWER CORPORATIONLDD2025-04-01
00817392026194UnipowerUNIPOWER CORPORATIONLDD2025-04-01
00817392026170UnipowerUNIPOWER CORPORATIONLDD2024-11-14
00817392025982UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392025999UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026002UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026019UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026026UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026033UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026040UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026057UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026064UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026071UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026088UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026095UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026101UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026118UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026125UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026132UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026149UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392026156UnipowerUNIPOWER CORPORATIONLDD2024-07-26
00817392025883UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025890UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025906UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025913UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025920UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025937UnipowerUNIPOWER CORPORATIONLDD2024-05-02
00817392025944UnipowerUNIPOWER CORPORATIONLDD2024-05-02