VORTRAN® APM-Plus
- Primary DI
- 10637320039600
- Brand
- VORTRAN® APM-Plus
- Company
- VORTRAN MEDICAL TECHNOLOGY 1, INC
- Model
- 3960
- Catalog number
- 3960
- Device description
- 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.
- Published
- 2020-01-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Anesthesiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K182292 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10637320039600 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10637320039600 | 10637320039600 |
GMDN Terms#
| Term | Definition |
|---|---|
| Airway pressure/oxygen monitor | A mains electricity (AC-powered) device designed to continuously measure and display the breathing circuit pressure and oxygen (O2) concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems such as continuous positive airway pressure (CPAP) systems or ventilator respiratory circuits. It typically includes pressure and O2 level displays, alarms to signal pressure and O2 levels that exceed specified limits, and has connectors to allow attachment to the respiratory equipment; it is used for neonatal, paediatrics and adults. It may contain one or more rechargeable battery for independent/mobile use or when mains power is not available. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 9166488460 | cvang@vortran.com |
Regulatory Flags#
- DUNS number
- 090508636
- Device count
- 1
- Serial number
- true
- No natural rubber latex
- true
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|---|---|---|---|---|
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| 10637320062004 | VORTRAN GO2VENT with PEEP Valve | 6200 | 6200 | 2021-05-04 |
| 20637320062001 | VORTRAN GO2VENT with PEEP Valve | 6200 | 6200 | 2021-05-04 |
| 10637320039006 | VORTRAN Airway Pressure Monitor | APM-3900 | APM-3900 | 2016-06-14 |
| 10637320060017 | VORTRAN GO2VENT | 6001 | 6001 | 2019-05-03 |
| 10637320000112 | VORTRAN GO2VENT | 6600 | 6600 | 2019-04-19 |
| 20637320050503 | VAR Surgical Center Kit | PCK-5050 | PCK-5050 | 2016-07-14 |
| 20637320060014 | VORTRAN GO2VENT | 6001 | 6001 | 2019-05-03 |
| 10637320000105 | VORTRAN GO2VENT | 6123 | 6123 | 2017-06-07 |
| 10637320000167 | VORTRAN GO2VENT | 6123-16 | 6123-16 | 2017-06-07 |
| 10637320024507 | VCI (VORTRAN Cuff Inflator) | 2450 | 2450 | 2018-08-31 |
| 10637320040200 | VORTRAN-IPPB | IP-4020 | IP-4020 | 2016-06-14 |
| 10637320040217 | VORTRAN-IPPB with Water Trap | IPW-4021 | IPW-4021 | 2016-06-14 |
| 10637320040224 | VORTRAN-IPPB with Manomter | IPM-4022 | IPM-4022 | 2016-06-14 |
| 10637320040309 | VORTRAN PercussiveNEB | PNB-4030 | PNB-4030 | 2016-06-14 |
| 10637320050001 | VAR (VORTRAN Automatic Resuscitator) | PT-5000 | PT-5000 | 2015-11-04 |
| 10637320050018 | VAR (VORTRAN Automatic Resuscitator) with Manometer | PTM-5001 | PTM-5001 | 2015-11-04 |
| 10637320050025 | VAR (VORTRAN Automatic Resuscitator) with Extension | PTE-5002 | PTE-5002 | 2015-11-04 |
| 10637320050100 | VAR (VORTRAN Automatic Resuscitator) | PC-5010 | PC-5010 | 2015-11-05 |
| 10637320050117 | VAR (VORTRAN Automatic Resuscitator) with Manometer | PCM-5011 | PCM-5011 | 2016-06-14 |
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