Vortran® APM-Plus
The VORTRAN APM-Plus monitors pressure from a positive-pressure breathing device connected to an adult or child weighing at least 10 kg. It is intended for professional use in hospitals and…
The VORTRAN APM-Plus monitors pressure from a positive-pressure breathing device connected to an adult or child weighing at least 10 kg. It is intended for professional use in hospitals and subacute institutions, including portable monitoring situations.
Pneumatic tubing carries pressure to the monitor’s solid-state sensor. The battery-powered processor displays the measurements on an LCD screen and compares pressure or breathing-rate values with user-set limits. Out-of-limit conditions trigger both visible and audible alarms.
Listed Item
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.
Monitoring Modes
PAP mode shows real-time breathing-circuit pressure. Resuscitator mode adds ventilation information such as respiratory rate, inspiratory and expiratory times, and their ratio. The unit monitors the connected device rather than providing ventilation.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 |
Record
| Listed by | Vortran Medical Technology 1, Inc., United States |
|---|---|
| FDA product code | CAP |
| Device type | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2600 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K182292 |
| Record published | 2020-01-30 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3960 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 24 |
| Manometer | Mercury Medical Enterprises, LLC | 18 |
| Jaeger | Jaeger Medical GmbH | 9 |
| Vyaire | Jaeger Medical GmbH | 8 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6 |
| Jitto | Galemed Corp. | 6 |
| Napa | DRW Medical | 5 |
| Micro Medical | Jaeger Medical GmbH | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | GE Healthcare Finland OY | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Galemed Corp. | 3 |
| Resuscitator Manometer POP OFF 60cmH2O(PC) | Besmed Health Business Corporation | 2 |
| Cuff Pressure Monitor Assembly | Instrumentation Industries, Incorporated | 2 |
Showing 12 of 44. All products under Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182292 | 2019-09-18 |
| K153733 | 2016-09-16 |
| K103639 | 2011-09-15 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N83074 | 1985-03-22 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.