Duns Number:090508636
Device Description: The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device t The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via the connection kit to monitor the cycling conditions of resuscitators. It give clinicians patient ventilation parameters (PIP, PEEP, Respiration Rate, I:E ratio) and provides visual alarm display with flashing LED and loud audible alarm. It allows clinicians to have a true value of patient status during ventilation similar to a full-featured ventilator. It is easy to set up and use. Offers different connection kit options.
Catalog Number
APM-3900
Brand Name
VORTRAN Airway Pressure Monitor
Version/Model Number
APM-3900
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
-
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
K103639
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
dad08cd2-75a2-4e1c-b1d7-04b7d15ecb29
Public Version Date
October 16, 2019
Public Version Number
4
DI Record Publish Date
June 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |