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 table
CodeName
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182292000VORTRAN APM-PlusVortran Medical Technology 1, Inc.2019-09-18CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10637320039600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1063732003960010637320039600

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure/oxygen monitorA 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
9166488460cvang@vortran.com

Regulatory Flags#

DUNS number
090508636
Device count
1
Serial number
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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10637320040309VORTRAN PercussiveNEBPNB-4030PNB-40302016-06-14
10637320050001VAR (VORTRAN Automatic Resuscitator)PT-5000PT-50002015-11-04
10637320050018VAR (VORTRAN Automatic Resuscitator) with ManometerPTM-5001PTM-50012015-11-04
10637320050025VAR (VORTRAN Automatic Resuscitator) with ExtensionPTE-5002PTE-50022015-11-04
10637320050100VAR (VORTRAN Automatic Resuscitator)PC-5010PC-50102015-11-05
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