FDA.report

R SERIES

Primary DI
00847946017583
Brand
R SERIES
Company
Zoll Medical Corporation
Model
30001006201310013
Device description
Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, SPO2, NIBP, DMST
Published
2014-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LLDPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
LLDPort & Catheter, Implanted, Subcutaneous, IntraperitonealGeneral Hospital2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions

SubmissionSupplement
K990762000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847946017583PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

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

Regulatory Flags

DUNS number
055363428
Device count
1
DM exempt
false
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

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Other Devices Sharing Product Codes

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
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