Catalog Number

-

Brand Name

Lifeguard

Version/Model Number

LG-22-100NY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2021

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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"

Yes

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

K013871,K013871

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

a0b30c50-1083-4a32-86d6-250fcfde44a7

Public Version Date

October 28, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-