Duns Number:002348191
Device Description: ET TUBE, UNCUFFED, SPIRAL-FLEX 5.0
Catalog Number
5-12910
Brand Name
HUDSON RCI
Version/Model Number
IPN044808
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K860105,K860105,K860105
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
96297aa1-38ee-41b0-8bb3-dc9da15cdbb4
Public Version Date
January 24, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2015
Package DI Number
24026704397499
Quantity per Package
5
Contains DI Package
04026704397495
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 |