Catalog Number

57-400

Brand Name

Guarded Luer Connector Female to Female

Version/Model Number

57-400

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,K173577

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

37fa3a62-148f-4312-b774-0a5a53a4d118

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

October 29, 2018

Package DI Number

B212574002

Quantity per Package

50

Contains DI Package

B212574001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box