Duns Number:206449154
Device Description: O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure i O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure is desired. This device provides a visual indication of air way pressure to be used on O_Two Single-use "open Circuit" CPAP System.
Catalog Number
01CV8066
Brand Name
O-Two Disposable Pressure manometer 0-20cmH2O
Version/Model Number
01CV8066
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"
Yes
For Single-Use
Yes
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
K102377,K102377
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
a77e4baa-2d2b-4729-96a3-b188822f41ed
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
17540195037004
Quantity per Package
25
Contains DI Package
07540195037007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Packaging box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |