FDA.reportPublic FDA data

ZENIX

Primary DI
00847946030926
Brand
ZENIX
Company
Zoll Medical Corporation
Model
8900-000421-01
Device description
ZENIX CPR AA ELECTRODE, SINGLE
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946030926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946030926008479460309268479460309260847946030926

GMDN Terms#

Term, Definition table
TermDefinition
Multifunction cardiac treatment electrodeAn electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

Regulatory Flags#

DUNS number
055363428
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
001988430062703100B HFOV11744-850K-402026-08-26
001988430062943100A HFOV29028-003-402026-08-26
001988430063003100A HFOV29028-004-402026-08-26
001988430063243100B HFOV29028-016-402026-08-26
001988430063623100 HFOV11437-PMN-402026-08-26
00198843003606Infant Flow™777010-402026-08-14
00198843003613Infant Flow™777012-402026-08-14
00198843003620Infant Flow™777014-402026-08-14
00198843003637Infant Flow™777016-402026-08-14
00198843003644Infant Flow™777018-402026-08-14
00198843003651Infant Flow™777020-402026-08-14
00198843003668Infant Flow™777022-402026-08-14
00198843003675Infant Flow™777024-402026-08-14
00198843003682Infant Flow™777026-402026-08-14
00198843003699Infant Flow™777028-402026-08-14
10847946030954ZENIX8900-000390-012026-08-14
00198843002913bellavista301.114.000-402026-07-22
00198843002920bellavista302.323.000-402026-07-22
00198843006614ZENIX8116-12-41-02000-00-USA2026-07-21
00198843006621ZENIX1116-100047-21-USA-02026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838126275PHILIPS HeartStart SMARTPADS IIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126282PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126299FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126473PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126480PHILIPS FR/FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
10847946030954ZENIXZoll Medical CorporationMKJ2026-08-14
00198843006614ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006621ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006638ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006645ZENIXZoll Medical CorporationMKJ2026-07-21
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)DEFIBTECH, L.L.C.MKJ2026-06-26
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031933LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032015LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032145LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
07613327673197LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673227LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673234LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673241LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673258LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18