Catalog Number

-

Brand Name

PharmGuard

Version/Model Number

21-2194-0403-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170982

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

1e44ce88-724e-4b63-8893-20371431e295

Public Version Date

February 04, 2020

Public Version Number

1

DI Record Publish Date

January 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-