FDA.reportPublic FDA data

X SERIES

Primary DI
00847946061784
Brand
X SERIES
Company
Zoll Medical Corporation
Model
601-2230011-01
Device description
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, DMST
Published
2023-10-24
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
false

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
00847946061784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946061784008479460617848479460617840847946061784

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable professional automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
10847946021327Cuffs9355-16402016-09-16
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16
10847946021358Cuffs9355-16432016-09-16
10847946021365Cuffs9355-16442016-09-16
10847946016354PEDI PADZ II8900-1005-012026-02-11
10847946016422PEDI PADZ8900-2501-012026-02-11
00847946053932AED PLUS206000003020110102023-01-25
00847946020767Model EMV+, Comm, MRI799-EMVP-052022-11-01
00847946020941AED 31028-0000012022-11-01
00198843000254ZENIX8116-12-40-02300-00-USA2025-10-06
00198843000278ZENIX8116-12-40-01300-00-USA2025-10-06
00198843000292ZENIX8116-12-41-02300-00-USA2025-10-06
00198843000315ZENIX8116-12-41-01300-00-USA2025-10-06
00198843000339ZENIX8116-12-41-02301-00-USA2025-10-06
00198843000353ZENIX8116-12-41-01301-00-USA2025-10-06
00198843000384ZENIX8116-14-41-01331-00-USA2025-10-06
00198843000599ZENIX8116-12-40-01000-00-USA2025-10-06
00812394022977ZENIX8116-12-40-02000-00-USA2025-10-06
00812394022984ZENIX8116-14-41-02331-00-USA2025-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10847946016354PEDI PADZ IIZoll Medical CorporationMKJ2026-02-11
10847946016422PEDI PADZZoll Medical CorporationMKJ2026-02-11
00198843000254ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000278ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000292ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000315ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000339ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000353ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000384ZENIXZoll Medical CorporationMKJ2025-10-06
00198843000599ZENIXZoll Medical CorporationMKJ2025-10-06
00812394022977ZENIXZoll Medical CorporationMKJ2025-10-06
00812394022984ZENIXZoll Medical CorporationMKJ2025-10-06
00847946053932AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056490AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056506AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056513AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056520AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056537AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056544AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056551AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056568AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056575AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056582AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056599AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056605AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056612AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056629AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056636AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056643AED PLUSZoll Medical CorporationMKJ2023-01-25
00847946056650AED PLUSZoll Medical CorporationMKJ2023-01-25