FDA.reportPublic FDA data

ECG

Primary DI
00847946021474
Brand
ECG
Company
Zoll Medical Corporation
Model
9500-000657-12
Device description
CABLE, 3 LEAD ECG, IEC, PROPAQ MD
Published
2016-09-16
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
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142915000ZOLL X SeriesZOLL Medical Corporation2014-12-03MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946021474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946021474008479460214748479460214740847946021474

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198843006454LTV18888-201-012026-09-18
00198843006492LTV18888-001-012026-09-18
00198843006515LTV18978-001-012026-09-18
00198843006539LTV18246-004-012026-09-18
00198843007352LTV18246-201-012026-09-18
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

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Primary DI, Brand, Company table
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