Catalog Number

57-401

Brand Name

Guarded Luer Connector Female to Male

Version/Model Number

57-401

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

02afeef7-a85b-415d-bafb-d1e918ff1e7a

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

October 29, 2018

Package DI Number

B212574012

Quantity per Package

50

Contains DI Package

B212574011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box