Hospital Wearable Defibrillator 10A0995

GUDID 00855778005159

ZOLL MANUFACTURING CORPORATION

Wearable defibrillation system

• Primary Device ID: 00855778005159
• NIH Device Record Key: 5129d280-16e7-4531-8857-f051a1c81264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hospital Wearable Defibrillator
• Version Model Number: HWD 1000 Monitor
• Catalog Number: 10A0995
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00855778005159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010030

FDA Product Code

• MVK: Wearable Automated External Defibrillator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-21

On-Brand Devices [Hospital Wearable Defibrillator]

• 10855778005279: HWD 1000 Therapy Electrode
• 00855778005203: HWD 1000 Electrode Cable
• 00855778005180: HWD 1000 Battery Pack
• 00855778005173: HWD 1000 Battery Charger
• 00855778005159: HWD 1000 Monitor