FDA.reportPublic FDA data

M SERIES CCT

Primary DI
00847946006495
Brand
M SERIES CCT
Company
Zoll Medical Corporation
Model
40021911100024010
Device description
Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,AC,DMST
Published
2014-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSKCOMPUTER, BLOOD-PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011865000ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIONZoll Medical Corp2001-07-31DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946006495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946006495008479460064958479460064950847946006495

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 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00847946018337Pro-Padz Radiotransparent8900-0051-402019-03-15
00847946021269Sensor9355-0005902016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSK2026-04-15
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDSK2025-12-09
00850022994456Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994463Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994470Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994487Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994524Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994531Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994548Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994555Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994401Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-09-08
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-08-22
00845225011420Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-03-24
00845225012762IVUS-PIMPhilips Image Guided Therapy CorporationDSK2025-03-24
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
00847946080525PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080532PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080563PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080570PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080587PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080600PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080617PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080648PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080341PROPAQ MZoll Medical CorporationDSK2024-03-05
00847946080358PROPAQ MZoll Medical CorporationDSK2024-03-05
00847946080365PROPAQ MZoll Medical CorporationDSK2024-03-05
00847946080389PROPAQ MZoll Medical CorporationDSK2024-03-05
00847946080426PROPAQ MZoll Medical CorporationDSK2024-03-05
00847946080457PROPAQ MZoll Medical CorporationDSK2024-03-05