VORTRAN® APM-Plus - The VORTRAN® APM-Plus is a battery (2 x AA) - VORTRAN MEDICAL TECHNOLOGY 1, INC

Duns Number:090508636

Device Description: The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, 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.

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More Product Details

Catalog Number

3960

Brand Name

VORTRAN® APM-Plus

Version/Model Number

3960

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182292

Product Code Details

Product Code

CAP

Product Code Name

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

Device Record Status

Public Device Record Key

872bcd23-bbc7-4cbe-bd89-c92349637b92

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VORTRAN MEDICAL TECHNOLOGY 1, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22