Duns Number:002348191
Device Description: RUSCH® Fox Post-Nasal Tube With 10cc Syringe, Red Rubber, Soft latex balloon
Catalog Number
568000
Brand Name
RUSCH
Version/Model Number
IPN044985
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
EMX
Product Code Name
BALLOON, EPISTAXIS
Public Device Record Key
080b290b-579b-4603-87dc-2df43d0f624d
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
September 15, 2018
Package DI Number
24026704543957
Quantity per Package
12
Contains DI Package
04026704543953
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |