Duns Number:529174252
Device Description: 60"(1500mm) Y Tubing with Single Check Valve
Catalog Number
801106B
Brand Name
LF
Version/Model Number
400102-3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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"
-
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
K182289,K182289,K182289
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
cf4dfc9d-d12a-42dd-bb57-05fae455a869
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 2021
Package DI Number
16938327906211
Quantity per Package
20
Contains DI Package
06938327906214
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 183 |