Duns Number:002348191
Device Description: Tracheostomy tube set, short
Catalog Number
120100-000090
Brand Name
RUSCH
Version/Model Number
IPN041798
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K964056,K964056,K964056
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
eacd4755-bfef-48de-a531-170ddebbf0bf
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
24026704010367
Quantity per Package
2
Contains DI Package
04026704010363
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 |