Model AEV (Tan, Commercial)

GUDID 00847946023478

Ventilator

Zoll Medical Corporation

Transport electric ventilator

• Primary Device ID: 00847946023478
• NIH Device Record Key: d63c67e0-8366-4e34-b3c4-2a20f4a1078f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model AEV (Tan, Commercial)
• Version Model Number: 799-AEV1-01-66
• 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

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946023478 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-18

On-Brand Devices [Model AEV (Tan, Commercial)]

• 00847946023478: Ventilator
• 00847946023461: Ventilator
• 00847946020651: Ventilator