PAD 3020-XLT

GUDID 00811331018097

ADAPTER-TEST HEARTSTREAM

Tz Medical, Inc.

External defibrillation electrode, adult, reusable

• Primary Device ID: 00811331018097
• NIH Device Record Key: b7bc03c5-e576-49a2-a437-b44b21632215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAD 3020-XLT
• Version Model Number: PAD 3020-XLT
• 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	00811331018097 [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: 2023-09-28
• Device Publish Date: 2023-09-20

Devices Manufactured by Tz Medical, Inc.

• 00811331013610 - Retractor Distractor: 2025-02-20 Right alignment distractor
• 00811331013634 - Retractor Distractor: 2025-02-20 Left alignment distractor
• 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