Duns Number:080456871
Device Description: Tracheal Tube Oral/Nasal with Pre-loaded Stylet
Catalog Number
8055RTC
Brand Name
RediTube™
Version/Model Number
8055RTC
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
5e941a6f-36c5-4bae-9c32-be5b62dcc42d
Public Version Date
April 12, 2021
Public Version Number
1
DI Record Publish Date
April 02, 2021
Package DI Number
20190752152370
Quantity per Package
40
Contains DI Package
50190752152371
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |