Duns Number:080456871
Device Description: Tracheal Tube Oral/Nasal with Pre-loaded Stylet
Catalog Number
8100RTC
Brand Name
RediTube™
Version/Model Number
8100RTC
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
19737da5-a33a-47ee-8697-679f7764d4b1
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
Package DI Number
50190752152432
Quantity per Package
160
Contains DI Package
10190752152434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |