Duns Number:002348191
Device Description: ET TUBE, HVT, EZ-ENDO, 8.5
Catalog Number
5-22517
Brand Name
HUDSON RCI
Version/Model Number
IPN044916
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
K822082,K822082
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
fd113f29-c90d-4875-9ad7-e981843268ea
Public Version Date
March 23, 2022
Public Version Number
8
DI Record Publish Date
October 16, 2015
Package DI Number
24026704398205
Quantity per Package
10
Contains DI Package
04026704398201
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 |