FDA.reportPublic FDA data

X SERIES

Primary DI
00847946045487
Brand
X SERIES
Company
Zoll Medical Corporation
Model
631-2221111-01
Device description
X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD/W INTERP, PACING, NIBP, SPO2, CPR EXPANSION PACKE AND ETCO2, DMSTC, REFURB
Published
2021-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DXNSystem, measurement, blood-pressure, non-invasive
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
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
00847946045487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946045487008479460454878479460454870847946045487

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
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
00847946030926ZENIX8900-000421-012026-08-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
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