DDU-2XXX Series ECGMA Cable, IEC

GUDID 00815098020522

DEFIBTECH, L.L.C.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID00815098020522
NIH Device Record Keyae3fdf59-465e-4af4-97a9-8fd983beda53
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-2XXX Series ECGMA Cable, IEC
Version Model NumberDAC-2021
Company DUNS128340200
Company NameDEFIBTECH, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815098020522 [Primary]

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

10815098020437 - DDU-1XX Series Pediatric Pads Configuration2023-07-06
10815098020451 - DDU-1XXX/2XXX Series Pediatric Pads Configuration2023-07-06
00815098020737 - DDU-100 Lifeline AED with RX activation form2021-08-09 DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year batte
00815098020744 - DDU-100 Lifeline AED with RX activation form2021-08-09 DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year batte
00815098020751 - DDU-120 Lifeline AED with RX activation form2021-08-09 DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year
00815098020768 - DDU-120 Lifeline AED with RX activation form2021-08-09 DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year
00815098020775 - DDU-2300 Lifeline VIEW with RX activation form2021-08-09 DDU-2300 Lifeline VIEW, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year b
00815098020782 - DDU-2450 Lifeline ECG with RX activation form2021-08-09 DDU-2450 Lifeline ECG, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year ba

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.