Duns Number:090508636
Device Description: The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the 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.
Catalog Number
6030
Brand Name
VORTRAN MANOMETER
Version/Model Number
6030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K153733,K153733
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
567d63fe-a48c-4f61-ab6e-5cacb48adbd0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 31, 2016
Package DI Number
20637320060304
Quantity per Package
10
Contains DI Package
10637320060307
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |