Duns Number:002348191
Device Description: SHER-I-SWIV/FO
Catalog Number
5-15401
Brand Name
HUDSON RCI
Version/Model Number
IPN048992
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
-
Product Code
BSR
Product Code Name
STYLET, TRACHEAL TUBE
Public Device Record Key
9d86f7d7-3731-467d-bda3-d20ecfb168df
Public Version Date
August 19, 2020
Public Version Number
2
DI Record Publish Date
September 20, 2018
Package DI Number
34026704617372
Quantity per Package
25
Contains DI Package
14026704617378
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 | 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 |