Duns Number:053469565
Device Description: Guarded Luer Connector Female Slip to Female Slip, Pink, Sterile, Box of 50 individual bli Guarded Luer Connector Female Slip to Female Slip, Pink, Sterile, Box of 50 individual blisters.
Catalog Number
57-403
Brand Name
Guarded Luer Connector Female Slip to Female Slip
Version/Model Number
57-403
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
K173577,K173577
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
9c722545-c471-4ba9-a8c7-5fc76d64fdb9
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
B212574032
Quantity per Package
50
Contains DI Package
B212574031
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |