Defibrillation Electrodes

GUDID 00811331010541

ADULT (STERILE), RADIOTRANSLUCENT ELEMENT

Tz Medical, Inc.

External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use
Primary Device ID00811331010541
NIH Device Record Key56447d68-2f8e-4e1a-a055-05d9b1addf39
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefibrillation Electrodes
Version Model NumberP-121-Z1
Company DUNS793149709
Company NameTz Medical, Inc.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811331010541 [Unit of Use]
GS100811331010565 [Primary]

FDA Product Code

DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-07
Device Publish Date2020-12-30

On-Brand Devices [Defibrillation Electrodes]

00811331010695LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
00811331010688LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEA
00811331010671LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
00811331010664LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
00811331010657ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEAD WIRE - K
00811331010640ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSLUCENT ELEMENT - KOREAN LABEL
00811331010466ADULT, W/LG. BACK PAD, STERILE RADIOTRANSPARENT ELEMENT AND LEAD WIRE
00811331010459ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT AND LEAD WIRE COMPATIBLE W/
00811331010442ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT AND LEAD WIRE
00811331010435ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT COMPATIBLE W/ MEDTRONIC
00811331010428PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ ZOLL
00811331010411PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC
00811331010404ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ ZOLL
00811331010398ADULT, RADIOTRANSPARENT ELEMENT AND LEAD WIRE
00811331010381ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ GRAY FLAT CONNECTOR
00811331010374ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC
00811331010367PEDIATRIC STERILE (3 X 3 1/4"), RADIOTRANSLUCENT ELEMENT
00811331010350ADULT (STERILE), RADIOTRANSLUCENT ELEMENT
00811331010343PEDIATRIC (3x3 1/4"), RADIOTRANSLUCENT ELEMENT
00811331010336ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ ZOLL
00811331010329ADULT, RADIOTRANSLUCENT ELEMENT
00811331010312ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ PHILLIPS GRAY FLAT CONNECTOR
00811331010305RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ MEDTRONIC
00811331011432ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ NIHON KOHDEN
00811331011418RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ NIHON KOHDEN
00811331011128ELECTRODE-MULTIFUNCTION, PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ PHILLIPS WHITE BARREL
00811331011104ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ PHILIPS WHITE BARREL
00811331011081ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ PHILIPS WHITE BARREL
00811331010602ADULT, W/LG. BACK PAD, STERILE RADIOTRANSPARENT ELEMENT AND LEAD WIRE
00811331010589PEDIATRIC STERILE (3 X 3 1/4"), RADIOTRANSLUCENT ELEMENT
00811331010541ADULT (STERILE), RADIOTRANSLUCENT ELEMENT
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.