Duns Number:022721133
Device Description: Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 37 F Parker Endo-Bronch with Standard Tip (Right Double-lumen Endobronchial Tube), PSTDR, 37 Fr Parker Original DID: 10749065861443.
Catalog Number
H-PSTDR-37
Brand Name
Parker
Version/Model Number
H-PSTDR-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
K092886,K092886
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
43c3a823-7544-4cf6-87a2-a8f3350c3a01
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 03, 2018
Package DI Number
10607411959551
Quantity per Package
10
Contains DI Package
00607411959554
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |