ZOLL Patch 10A1067

GUDID 00855778005258

ZOLL MANUFACTURING CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00855778005258
• NIH Device Record Key: 6f0e9368-cce7-4df3-a249-c1957a702fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL Patch
• Version Model Number: Patch
• Catalog Number: 10A1067
• Company DUNS: 079320559
• Company Name: ZOLL MANUFACTURING CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855778005258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172510

FDA Product Code

• DSB: Plethysmograph, Impedance

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-05-17

Devices Manufactured by ZOLL MANUFACTURING CORPORATION

• 00855778005456 - uCor Heart Failure and Arrhythmia Management System: 2023-06-30
• 00855778005463 - ZOLL Arrhythmia Management System: 2023-06-30
• 00855778005357 - ZOLL Arrhythmia Management System: 2020-10-29
• 00855778005364 - ZOLL Arrhythmia Management System: 2020-10-29
• 00855778005210 - LifeVest Wearable Defibrillator: 2020-08-19
• 00855778005258 - ZOLL Patch: 2020-02-06
• 00855778005258 - ZOLL Patch: 2020-02-06
• 00855778005302 - uCor Heart Failure and Arrhythmia Management System: 2020-02-06
• 00855778005319 - ZOLL Charger: 2020-02-06