Duns Number:079105071
Device Description: 14F x 24cm Schon XL Double Lumen (Short Term)
Catalog Number
-
Brand Name
Schon
Version/Model Number
10801703
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
LFJ
Product Code Name
CATHETER, SUBCLAVIAN
Public Device Record Key
50b78866-c176-47b8-8fef-daaa5605113a
Public Version Date
November 03, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2015
Package DI Number
H787108017035
Quantity per Package
10
Contains DI Package
H787108017030
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |