AGILE TEST

GUDID 00847946099039

AGILE TEST 8.62A

Zoll Medical Corporation

Transport electric ventilator

• Primary Device ID: 00847946099039
• NIH Device Record Key: 0d79751b-fae7-4fa7-9599-95ca966de47c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILE TEST
• Version Model Number: TEST 8.6.A
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946099039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111473

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-01-30

On-Brand Devices [AGILE TEST]

• 00847946099039: AGILE TEST 8.62A
• 00847946020613: TEST
• 00847946020576: AGILE TEST
• 00847946020569: AGILE TEST
• 00847946020552: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M
• 00847946020545: Defibrillator ,MAIN, AGILE TEST