Duns Number:022721133
Device Description: Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 35 Fr, Parker Endo-Bronch with Flex-Tip (Left Double-lumen Endobronchial Tube), PFTDL , 35 Fr, O.D 10.5mm, I.D 4.0mm
Catalog Number
H-PFTDL-35
Brand Name
Parker Flex-Tip
Version/Model Number
H-PFTDL-35
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
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
e5b4b15d-1ed5-4c23-99ef-0e88ca408bff
Public Version Date
June 19, 2019
Public Version Number
3
DI Record Publish Date
January 31, 2016
Package DI Number
50749065061407
Quantity per Package
20
Contains DI Package
10749065061409
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 |