FDA.reportPublic FDA data

DDU-1XXX/2XXX Series Adult Rescue Pads

Primary DI
00815098020447
Brand
DDU-1XXX/2XXX Series Adult Rescue Pads
Company
DEFIBTECH, L.L.C.
Model
DDP-2001
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K081259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081259000DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC2009-06-15MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815098020448PackageGS110In Commercial Distribution
50815098020442PackageGS14In Commercial Distribution
00815098020447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081509802044830815098020448
5081509802044250815098020442
00815098020447008150980204478150980204470815098020447

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128340200
Device count
1
Lot or batch
true
Expiration date on label
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