Defibrillation Electrodes

GUDID 00811331010343

PEDIATRIC (3x3 1/4"), RADIOTRANSLUCENT ELEMENT

Tz Medical, Inc.

External defibrillator electrode pad

• Primary Device ID: 00811331010343
• NIH Device Record Key: 44858bc0-7d75-4fff-80ea-b6e6541a2579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defibrillation Electrodes
• Version Model Number: P-112-T1
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811331010343 [Unit of Use]
GS1	10811331010340 [Primary]

FDA Product Code

• DRO: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-07
• Device Publish Date: 2020-12-30

On-Brand Devices [Defibrillation Electrodes]

• 00811331010695: LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
• 00811331010688: LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEA
• 00811331010671: LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
• 00811331010664: LEADS OUT ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT, COMPATI
• 00811331010657: ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSPARENT ELEMENT AND LEAD WIRE - K
• 00811331010640: ELECTRODE-MULTIFUNCTION, ADULT, RADIOTRANSLUCENT ELEMENT - KOREAN LABEL
• 00811331010466: ADULT, W/LG. BACK PAD, STERILE RADIOTRANSPARENT ELEMENT AND LEAD WIRE
• 00811331010459: ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT AND LEAD WIRE COMPATIBLE W/
• 00811331010442: ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT AND LEAD WIRE
• 00811331010435: ADULT, W/LG. BACK PAD, RADIOTRANSPARENT ELEMENT COMPATIBLE W/ MEDTRONIC
• 00811331010428: PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ ZOLL
• 00811331010411: PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC
• 00811331010404: ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ ZOLL
• 00811331010398: ADULT, RADIOTRANSPARENT ELEMENT AND LEAD WIRE
• 00811331010381: ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ GRAY FLAT CONNECTOR
• 00811331010374: ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC
• 00811331010367: PEDIATRIC STERILE (3 X 3 1/4"), RADIOTRANSLUCENT ELEMENT
• 00811331010350: ADULT (STERILE), RADIOTRANSLUCENT ELEMENT
• 00811331010343: PEDIATRIC (3x3 1/4"), RADIOTRANSLUCENT ELEMENT
• 00811331010336: ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ ZOLL
• 00811331010329: ADULT, RADIOTRANSLUCENT ELEMENT
• 00811331010312: ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ PHILLIPS GRAY FLAT CONNECTOR
• 00811331010305: RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ MEDTRONIC
• 00811331011432: ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ NIHON KOHDEN
• 00811331011418: RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ NIHON KOHDEN
• 00811331011128: ELECTRODE-MULTIFUNCTION, PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ PHILLIPS WHITE BARREL
• 00811331011104: ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ PHILIPS WHITE BARREL
• 00811331011081: ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ PHILIPS WHITE BARREL
• 00811331010602: ADULT, W/LG. BACK PAD, STERILE RADIOTRANSPARENT ELEMENT AND LEAD WIRE
• 00811331010589: PEDIATRIC STERILE (3 X 3 1/4"), RADIOTRANSLUCENT ELEMENT
• 00811331010541: ADULT (STERILE), RADIOTRANSLUCENT ELEMENT