FDA.reportPublic FDA data

X SERIES

Primary DI
00847946030438
Brand
X SERIES
Company
Zoll Medical Corporation
Model
631-2271211-01
Device description
X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, SPO2, SPCO, SPMET, SPHB, SPOC PVI, PI (RAINBOW), BVM/TEMP, CPR EXTENDED INSTALLED, US, REFURB
Published
2020-11-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102174000ZOLL PROPAQ MZoll Medical Corporation, World Wide Headquarters2010-09-15DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946030438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946030438008479460304388479460304380847946030438

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004040-012026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004041-012026-05-29
00847946021986HWD Electrode Set9610-000181-012016-10-20
10847946021327Cuffs9355-16402016-09-16
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16
10847946021358Cuffs9355-16432016-09-16
10847946021365Cuffs9355-16442016-09-16
00847946023058ACCUVENT9500-0006632022-11-01
10847946023130PATIENT CIRCUITS812-0008-202022-06-08
10847946023123PATIENT CIRCUITS812-0007-202015-10-28
10847946023147PATIENT CIRCUITS812-0009-202015-10-28
10847946023154PATIENT CIRCUITS812-0010-202015-10-28
10847946023161PATIENT CIRCUITS812-0011-202015-10-28
10847946023215PATIENT CIRCUITS712-0002-202020-10-22
00847946026929RESQPOD ITD 1012-0242-0002020-06-24
20847946023137PATIENT CIRCUITS812-0008-402015-10-28
20847946023182PATIENT CIRCUITS812-0007-402015-10-28
00847946016746ZOLL CABLE1009-0918-012014-09-24
00847946016760ZOLL CABLE1009-0913-022014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
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
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDSK2025-12-09
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
10009336010322Zoll PL DefibGRAPHIC CONTROLS ACQUISITION CORPMKJ2023-10-30
10653405046813CONMEDConmed CorporationMKJ2023-10-19
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033019AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033132AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033149AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033163AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033170AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
00191506042080AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDSK2023-10-10
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDSK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDSK2023-04-19
00195278524089NAGE Healthcare Finland OyDSK2023-04-19