Duns Number:002348191
Device Description: ET TUBE, SHER-I-BRONCH, RS, 28 FR
Catalog Number
5-16128
Brand Name
HUDSON RCI
Version/Model Number
IPN048999
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
K851856,K851856,K851856,K851856
Product Code
CBI
Product Code Name
TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Public Device Record Key
e15edb2e-a156-492c-9cf2-807edc7666ed
Public Version Date
November 15, 2021
Public Version Number
9
DI Record Publish Date
September 20, 2018
Package DI Number
34026704617433
Quantity per Package
1
Contains DI Package
14026704617439
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 |