Duns Number:090508636
Device Description: The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and m The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.
Catalog Number
2450
Brand Name
VCI (VORTRAN Cuff Inflator)
Version/Model Number
2450
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
-
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
K173914,K173914
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
e72e2323-4625-4882-bc55-d3a87a5f749e
Public Version Date
March 21, 2019
Public Version Number
2
DI Record Publish Date
August 31, 2018
Package DI Number
20637320024504
Quantity per Package
10
Contains DI Package
10637320024507
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 |