Duns Number:022721133
Device Description: Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 37 Fr, Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 37 Fr, O.D 11.5mm, I.D 4.4mm
Catalog Number
H-PSTDL-37
Brand Name
Parker Flex-Tip
Version/Model Number
H-PSTDL-37
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
09eadcf2-0729-4152-bf62-51240660e812
Public Version Date
June 19, 2019
Public Version Number
3
DI Record Publish Date
January 02, 2017
Package DI Number
50749065851442
Quantity per Package
20
Contains DI Package
10749065851444
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 |