Duns Number:058716649
Device Description: Female Luer Transfer Set(TRANSFER SET,LUER, MC)(60729113)
Catalog Number
FTS
Brand Name
Female Luer Transfer Set
Version/Model Number
FTS
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
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
e6c4e838-32ec-479a-99a3-bd448642e0e1
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258005741
Quantity per Package
50
Contains DI Package
00616258005744
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |