Duns Number:627572217
Device Description: ENDOTRACHEAL TUBE, CUFFED, SIZE: 10.0MM
Catalog Number
9003016
Brand Name
CUSTOMED
Version/Model Number
712057143016
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
d44506fd-f362-4b14-a42b-a7248712f53d
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
M20890030161
Quantity per Package
10
Contains DI Package
M20890030160
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10/BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |