Catalog Number

-

Brand Name

IMMY

Version/Model Number

TBP300

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

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

PPM

Product Code Name

General Purpose Reagent

Public Device Record Key

d0f670b5-23e2-44ab-8c11-7fe54d9d0238

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2018

Package DI Number

00816387021077

Quantity per Package

5

Contains DI Package

00816387021084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-