FDA.reportPublic FDA data

Artisan Power

Primary DI
00819595017023
Brand
Artisan Power
Company
Artisan Power LLC
Model
MB-30344270-N
Device description
GE MAC 1000, MAC1100, MAC 1200, MAC1300, Cardio Smart EKG Replacement Battery
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOQBattery, Replacement, Rechargeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819595017023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819595017023008195950170238195950170230819595017023

GMDN Terms#

Term, Definition table
TermDefinition
Secondary batteryA 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 size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978-562-4300sales@artisanpower.com

Regulatory Flags#

DUNS number
619057339
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819595011175Artisan PowerSB-MB200-L2026-02-10
00819595015029Artisan PowerMB-BATT22-L2026-02-10
00819595015661Artisan PowerMB-TSE1-L2026-02-10
00819595015685Artisan PowerMB-AED10-L2026-02-10
00819595015692Artisan PowerMB-B11261-N2026-02-10
00819595015876Artisan PowerMB-SM201-L2026-02-10
00819595015906Artisan PowerMB-M8-L2026-02-10
00819595015944Artisan PowerMB-72420-L2026-02-10
00819595016040Artisan PowerMB-71960-L2026-02-10
00819595016118Artisan PowerMB-72200-N2026-02-10
00819595016125Artisan PowerMB-72300-N2026-02-10
00819595016149Artisan PowerMB-903466-L_P2026-02-10
00819595016163Artisan PowerMB-B11453-LAB2026-02-10
00819595016750Artisan PowerMB-BATT99-L2026-02-10
00819595016781Artisan PowerMB-LOGS8-L2026-02-10
00819595016828Artisan PowerMB-B11435-N2026-02-10
00819595016880Artisan PowerMB-26503-L2026-02-10
00819595016897Artisan PowerMB-R3-L2026-02-10
00819595016910Artisan PowerMB-0079-L2026-02-10
00819595016934Artisan PowerMB-T1-L2026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934726614453Battery PackLongfian Scitech Co., Ltd.MOQ2026-04-25
30845854052079HALLConmed CorporationMOQ2026-04-01
00819595011175Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015029Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015661Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015685Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015692Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015876Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015906Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015944Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016040Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016118Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016125Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016149Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016163Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016750Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016781Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016828Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016880Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016897Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016910Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016934Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016941Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016958Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016965Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016972Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017092Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017108Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017115Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017122Artisan PowerArtisan Power LLCMOQ2026-02-10