Catalog Number

80-110

Brand Name

SALINE LOCK KIT

Version/Model Number

04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2022

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

-

Product Code

LRS

Product Code Name

I.V. Start Kit

Public Device Record Key

e22932d5-ab98-4406-bda7-473f618cedd0

Public Version Date

April 12, 2022

Public Version Number

5

DI Record Publish Date

October 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-