Catalog Number

57-400W

Brand Name

Guarded Luer Connector Female to Female

Version/Model Number

57-400W

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

4a2f00b2-1d86-42bb-b872-0316efeaba43

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

B21257400W2

Quantity per Package

50

Contains DI Package

B21257400W1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box