FDA.reportPublic FDA data

R SERIES

Primary DI
00847946002381
Brand
R SERIES
Company
Zoll Medical Corporation
Model
30000000301110013
Device description
Defibrillator ,R SERIES, MAIN, PLUS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST
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
DPSELECTROCARDIOGRAPH
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990762000ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)Zoll Medical Corp1999-09-03MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946002381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946002381008479460023818479460023810847946002381

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic-monitoring defibrillation systemAn assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

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 Celsius55 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity5 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
00198843002876bellavista302.396.000-402026-07-06
00198843001145bellavista301.328.020-402026-06-24
00198843001152bellavista301.470.020-402026-06-24
00198843003347Infant Flow™777000XS-402026-06-24
00198843003361Infant Flow™777000S-402026-06-24
00198843003385Infant Flow™777000M-402026-06-24
00198843003408Infant Flow™777000L-402026-06-24
00198843003422Infant Flow™777000XL-402026-06-24
00198843003545Infant Flow™777040XS-402026-06-24
00198843003552Infant Flow™777040S-402026-06-24
00198843003569Infant Flow™777040SM-402026-06-24
00198843003576Infant Flow™777040M-402026-06-24
00198843003583Infant Flow™777040L-402026-06-24
00198843003590Infant Flow™777040XL-402026-06-24
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

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10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
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