Catalog Number

21-2193-0402-25

Brand Name

PharmGuard

Version/Model Number

2193

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

b753391a-a973-4fba-ad25-d72f193be4e1

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

September 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-