Duns Number:002348191
Device Description: ETT with Suction, PVC, 8.0
Catalog Number
112090080
Brand Name
RUSCH
Version/Model Number
D129689
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
K110269,K110269,K110269
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
68891a25-c1aa-4bd9-b360-1f1091e5d40e
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 2019
Package DI Number
34026704647775
Quantity per Package
10
Contains DI Package
24026704647778
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |