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TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P200005Ref P-311-T1

by Tz Medical, Inc.

Identity

Trade Name
TZ DEFIBRILLATOR ELECTRODES EUDAMED
TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors FDA PMA
Defibrillation Electrodes FDA UDI
Generic Name
Automated external defibrillators (non-wearable) FDA PMA
Electrode conductive skin pad, single-use FDA UDI
Device Name
TZ DEFIBRILLATOR ELECTRODES EUDAMED
LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEA FDA UDI
Model / Reference
P-311-T1 EUDAMEDFDA UDI
Description
LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEA FDA UDI

Identifiers

Primary DI / UDI-DI
00811331010688 EUDAMED
10811331010685 FDA UDI
Basic UDI-DI
B-00811331010688 EUDAMED
PMA Number
P200005 FDA PMA
FDA Product Code
MKJ FDA PMA
DRO FDA UDI
EMDN Code
Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
GMDN Term
Electrode conductive skin pad, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class III FDA PMA
Class II FDA UDI
Legislation / Framework
21 CFR Part 870.5310 FDA PMA
Regulation Number
870.5310 FDA PMA
870.5550 FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors are components designed for use with automated external defibrillators. These devices facilitate the delivery of electrical therapy to the heart, supporting cardiovascular resuscitation efforts in clinical or emergency settings.

The product line includes multi-function defibrillation electrodes and adaptors available in both adult and pediatric configurations. These medical devices are manufactured by Tz Medical, Inc. and are authorized under FDA PMA and MDD regulatory frameworks.

Frequently asked questions

Are these electrodes suitable for both adults and children?

Yes, the product line includes specific multi-function defibrillation electrodes and adaptors designed for both adult and pediatric patients to ensure appropriate application.

What type of equipment are these accessories compatible with?

These accessories are designed for use with non-wearable automated external defibrillators, serving as the interface between the device and the patient.

Is this device authorized for use?

Yes, the TZ Medical defibrillation components are authorized under FDA PMA and MDD regulatory requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

MDD

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Tz Medical, Inc.

Sources (3)

  • FDA PMA P200005 24 fields · synced Oct 6, 2026
  • FDA UDI 47f8040e-cdf5-45be-ad13-f0e7c06ad9bb 33 fields · synced May 30, 2026
  • EUDAMED 99a17c25-dd62-4ba1-8015-628078dc7784 61 fields · synced Jul 17, 2026