Duns Number:002348191
Catalog Number
170155
Brand Name
RUSCH
Version/Model Number
IPN914323
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K780900,K780900,K780900
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
15a4466e-d051-47af-8ef8-c62498f8ad19
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
December 13, 2018
Package DI Number
24026704644944
Quantity per Package
10
Contains DI Package
14026704644947
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |