PAD 3020-ZMI

GUDID 00811331018103

ADAPTER- TEST SINGLE PC DUAL

Tz Medical, Inc.

External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable External defibrillation electrode, adult, reusable

• Primary Device ID: 00811331018103
• NIH Device Record Key: 50a6bd5e-8a27-474e-8a29-537a87e8e0da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAD 3020-ZMI
• Version Model Number: PAD 3020-ZMI
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811331018103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983196

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: 2023-09-28
• Device Publish Date: 2023-09-20

Devices Manufactured by Tz Medical, Inc.

• 00811331011470 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Large
• 00811331011333 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Small
• 00811331013917 - H3R USB Cable: 2023-11-23 H3R USB Cable
• 00811331013931 - H3R Holster: 2023-11-23 H3R Holster (Rev A)
• 00811331013245 - TZ Medical Pressure Discs: 2023-10-30 Round Universal Disc
• 00811331011210 - EZ Holder: 2023-10-30 EZ Holder
• 00811331011647 - TruBrite Adhesive Retractor Light: 2023-10-30 Adhesive Retractor Light
• 00811331011715 - TZ Medical Pressure Discs: 2023-10-30 Oval Universal Disc