FDA.reportPublic FDA data

R SERIES

Primary DI
00847946002107
Brand
R SERIES
Company
Zoll Medical Corporation
Model
10000007201310013
Device description
Defibrillator ,MAIN, R SERIES, PLUS, NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, NIBP, CF/USB, REFURB
Published
2014-09-19
Public version status
Update
Distribution status
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
K120907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120907000ZOLL R SERIESZoll Medical Corporation, World Wide Headquarters2012-09-25MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946002107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946002107008479460021078479460021070847946002107

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 Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 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
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06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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