Duns Number:022721133
Device Description: Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 6.5mm
Catalog Number
H-PFST-65
Brand Name
Parker Flex-Tip
Version/Model Number
H-PFST-65
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
-
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
1e0aa5f6-beac-45e1-b994-64bee17fd878
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
October 27, 2015
Package DI Number
50749065801652
Quantity per Package
10
Contains DI Package
30749065801658
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |