POWER INFUSER

GUDID 00847946098964

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946098964
• NIH Device Record Key: e870f36b-ea13-49df-bc0d-d48bace3a127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWER INFUSER
• Version Model Number: 1110-0013-01
• 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: 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 Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946098964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062537

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

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: 2016-06-08

On-Brand Devices [POWER INFUSER]

• 00847946098964: 1110-0013-01
• 00847946021603: PUMP CARTRIDGE, BLOOD, 10 PER CASE (IPN 0040-0051)
• 00847946021597: PUMP CARTRIDGE, CRYSTALLOID/COLLOID, 10 PER CASE (IPN 0040-0050)