AED PRO

GUDID 00847946016128

Defibrillator ,ASSY, MAIN, SEMI AUTO W/MNL OVERRIDE, NO VOICE, AED PRO, ENGLISH

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946016128
• NIH Device Record Key: d44f358e-8133-407a-b83c-d6c3148b2be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED PRO
• Version Model Number: 90010200499991010
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946016128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110526

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: 2014-09-10

On-Brand Devices [AED PRO]

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• 00847946016166: Defibrillator ,ASSY, MAIN, MANUAL ONLY, NO VOICE, LCD, AED PRO, ENGLISH
• 00847946016159: Defibrillator ,ASSY, MAIN, SEMI AUTOMATIC ONLY, VOICE, AED PRO, ENGLISH
• 00847946016142: Defibrillator ,ASSY, MAIN, SEMI AUTOMATIC ONLY, NO VOICE, AED PRO, ENGLISH
• 00847946016135: Defibrillator ,ASSY, MAIN, SEMI AUTO W/MNL OVERRIDE, VOICE, AED PRO, ENGLISH
• 00847946016128: Defibrillator ,ASSY, MAIN, SEMI AUTO W/MNL OVERRIDE, NO VOICE, AED PRO, ENGLISH
• 00847946097691: AED PRO, SEMI-AUTO W/MNL OVERRIDE, ( 1 CPR-D PAD), ENG, PLUSTRAC5
• 00847946097684: AED PRO, SEMI-AUTO W/MNL OVERRIDE, (1 CPR-D PAD), ENG, PLUSTRAC1G
• 00847946097677: AED PRO, SEMI-AUTO W/MNL OVERRIDE, (1 CPR-D PAD), ENG, PLUSMED1
• 00847946097660: AED PRO, SEMI-AUTO/MANUAL, CARRY CASE, BOSTON EMS
• 00847946097042: AED PRO, SEMI AUTO W/MNL OVERRIDE, NO VOICE, LCD, ENGLISH
• 00847946096892: AED PRO, SEMI AUTO ONLY, NO BATTERY, VOICE, LCD, ENGLISH
• 00847946096830: AED PRO, SEMI AUTO W/MNL OVERRIDE, ENGLISH
• 00847946096816: AED PRO, SEMI AUTOMATIC/MANUAL OVERRIDE, NO BATTERY, VOICE, LCD, ENGLISH
• 00847946096472: AED PRO, SEMI AUTO W/MNL OVERRIDE, NO VOICE, LCD, ENGLISH, REFURB
• 00847946096298: AED PRO, SEMI AUTOMATIC ONLY, NO BATTERY, NO ELECTRODES, REFURB