Duns Number:058614483
Device Description: Endobronchial Suction Catheters with Color Coded Connectors, Endobronchial Tube Right with Endobronchial Suction Catheters with Color Coded Connectors, Endobronchial Tube Right with CPAP, Endobronchial Tube Accessories, (2) Right Angle Swivel Connectors; Carlens Y Adapter
Catalog Number
-
Brand Name
Shiley
Version/Model Number
126135
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"
-
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
K912240
Product Code
BYE
Product Code Name
Attachment, breathing, positive end expiratory pressure
Public Device Record Key
c3528b78-6c38-41de-89c4-f90c996bea5b
Public Version Date
January 10, 2022
Public Version Number
3
DI Record Publish Date
March 21, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |