Duns Number:053146767
Device Description: The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient airway pressure during ventilation with a manual resuscitation device or bag/mask unit. This device is intended to be used by or on the order of a physician.
Catalog Number
NS 120P-TRS
Brand Name
NS 120P-TRS Airway Pressure Monitor
Version/Model Number
NS 120P-TRS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K180510
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
504c7d00-d023-48ca-93e4-24e31d930cec
Public Version Date
June 24, 2019
Public Version Number
1
DI Record Publish Date
June 15, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |