Duns Number:079375431
Device Description: ADULT 7.5 MM ET TUBE WITH SUBGLOTTIC SUCTIONING
Catalog Number
13221
Brand Name
Halyard
Version/Model Number
13221
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
-
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
0ba65532-1959-42e0-a1ba-5d24007831c7
Public Version Date
November 16, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2015
Package DI Number
30680651132216
Quantity per Package
10
Contains DI Package
10680651132212
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 | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |