Duns Number:324869601
Device Description: Connecting Tube for Cuff Pressure Control
Catalog Number
-
Brand Name
N/A
Version/Model Number
54-05-112
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
K912723,K912723
Product Code
BSK
Product Code Name
Cuff, Tracheal Tube, Inflatable
Public Device Record Key
0c21724b-f219-4914-a94f-5fa0261de794
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
January 17, 2016
Package DI Number
14250105604297
Quantity per Package
10
Contains DI Package
04250105604290
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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |