ZOLL MFC

GUDID 00847946018313

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946018313
• NIH Device Record Key: a8225693-03ea-4e85-9ad8-da7202da5b50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL MFC
• Version Model Number: 1009-0913-04
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946018313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120907

FDA Product Code

• DRT: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

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: 2014-09-24

On-Brand Devices [ZOLL MFC]

• 00847946099671: CABLE ASSY, MFC-CPRD, X SERIES
• 00847946018320: 1009-0913-05
• 00847946018313: 1009-0913-04
• 00847946016807: 1007-0196-01
• 00847946016777: 1009-0913-03
• 00847946016692: 1001-0196-02
• 00847946055998: CABLE ASSY, MFC-CPRD, X SERIES