VORTRAN® APM-Plus 3960

GUDID 10637320039600

The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or bubble CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure and includes a number of associated accessories. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode.

VORTRAN MEDICAL TECHNOLOGY 1, INC

Airway pressure/oxygen monitor

• Primary Device ID: 10637320039600
• NIH Device Record Key: 872bcd23-bbc7-4cbe-bd89-c92349637b92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VORTRAN® APM-Plus
• Version Model Number: 3960
• Catalog Number: 3960
• Company DUNS: 090508636
• Company Name: VORTRAN MEDICAL TECHNOLOGY 1, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9166488460
• Email: cvang@vortran.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10637320039600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182292

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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: 2020-02-07
• Device Publish Date: 2020-01-30

Devices Manufactured by VORTRAN MEDICAL TECHNOLOGY 1, INC

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