FDA.reportPublic FDA data

AGILE TEST

Primary DI
00847946020545
Brand
AGILE TEST
Company
Zoll Medical Corporation
Model
DB-1000
Device description
Defibrillator ,MAIN, AGILE TEST
Published
2020-01-19
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
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DQAOximeter
DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
LDDDc-defibrillator, low-energy, (including paddles)
LIXAid, cardiopulmonary resuscitation
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)Cardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2
LIXAid, Cardiopulmonary ResuscitationCardiovascular2
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
00847946020545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946020545008479460205458479460205450847946020545

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198843002852bellavista301.115.010-012026-07-10
00198843002869bellavista301.115.020-012026-07-10
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

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