Duns Number:830432451
Device Description: RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet
Catalog Number
8080RTC
Brand Name
RediTube™
Version/Model Number
8080RTC
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
K042683,K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
7d490cd0-8922-478b-90f6-31fafcea0888
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
August 29, 2016
Package DI Number
50885403296084
Quantity per Package
4
Contains DI Package
20885403296083
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |