FDA.reportPublic FDA data

Lifeline Pro

Primary DI
00815098020249
Brand
Lifeline Pro
Company
DEFIBTECH, L.L.C.
Model
DDU-A2400
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121853000DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC2012-12-13MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815098020249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815098020249008150980202498150980202490815098020249

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable professional semi-automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128340200
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815098020475DDU-1XX Series Adult Pads Adapter, Physio-Control ConfigurationDAC-300E2015-10-23
10815098020482DDU-1XX Series Adult Pads Adapter, Zoll ConfigurationDAC-310E2015-10-24
10815098020499DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control ConfigurationDAC-20002015-10-24
10815098020505DDU-1XXX/2XXX Adult Pads Adapter, Zoll ConfigurationDAC-20102015-10-24
00815098020478DDU-1XX Series Adult Pads Adapters, Physio-ControlDAC-300E2015-10-24
00815098020485DDU-1XX Series Adult Pads Adapters, ZollDAC-310E2015-10-24
00815098020492DDU-1XXX/2XXX Series Adult Pads Adapter, Physio-ControlDAC-20002015-10-24
00815098020508DDU-1XXX/2XXX Series Adult Pad Adapters, ZollDAC-20102015-10-24
00815098021482Lifeline VIEW 2DDU-29502025-12-09
00815098021512Lifeline VIEW 2 AutoDDU-29552025-12-09
00815098021536Lifeline ECG 2DDU-29602025-12-09
00815098021550DDU-29XX series, universal pad, single pairDDP-20042025-12-09
10815098021496Lifeline VIEW 2 AED configurationDDU-29502025-12-09
10815098021526Lifeline VIEW 2 AUTO AED configurationDDU-29552025-12-09
10815098021540Lifeline ECG 2 AED configurationDDU-29602025-12-09
30815098021568Pads, DDU-29XX series, universal pad, 10 pairsDDP-20042025-12-09
50815098021579Pads, DDU-29XX series, universal pad, 40 pairsDDP-20042025-12-09
10815098020529DDU-2XXX Series ECGMA Cable, IEC ConfigurationDAC-20212015-10-24
00815098020522DDU-2XXX Series ECGMA Cable, IECDAC-20212015-10-24
00815098020010LifeforceDDU-100C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
10009336010322Zoll PL DefibGRAPHIC CONTROLS ACQUISITION CORPMKJ2023-10-30
10653405046813CONMEDConmed CorporationMKJ2023-10-19
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
10884838002859HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-02-25
10884838002842HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017622Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253018865Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017578Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017585Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017639Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018872Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05