VORTRAN MANOMETER
- Primary DI
- 10637320060307
- Brand
- VORTRAN MANOMETER
- Company
- VORTRAN MEDICAL TECHNOLOGY 1, INC
- Model
- 6030
- Catalog number
- 6030
- Device description
- The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.
- Published
- 2016-10-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Single use
- 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 |
|---|---|
| K153733 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20637320060304 | Package | GS1 | 10 | In Commercial Distribution |
| 10637320060307 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20637320060304 | 20637320060304 |
| 10637320060307 | 10637320060307 |
GMDN Terms#
| Term | Definition |
|---|---|
| Airway pressure monitor, non-powered | A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| 916-648-8460 | vyang@vortran.com |
Regulatory Flags#
- DUNS number
- 090508636
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
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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 |
| 10637320039600 | VORTRAN® APM-Plus | 3960 | 3960 | 2020-01-30 |
| 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 |
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