Cuffs

GUDID 00847946021368

neonate Cuff # 5 single

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946021368
• NIH Device Record Key: fac3695f-c4fc-4519-8024-4ec1dffeb535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cuffs
• Version Model Number: 9355-1660
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: true
• 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: 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	00847946021368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120907

FDA Product Code

• DXN: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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: 2016-09-16

On-Brand Devices [Cuffs]

• 00847946021368: neonate Cuff # 5 single
• 00847946021351: neonate Cuff # 4 single
• 00847946021344: neonate Cuff # 3 single
• 00847946021337: neonate Cuff # 2 single
• 00847946021320: neonate Cuff # 1 single