Catalog Number

-

Brand Name

Chilling Block

Version/Model Number

2 syringes + 3 vials

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

-

Product Code

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Public Device Record Key

7d9f0288-42b2-4572-910f-ab0f3deada62

Public Version Date

April 22, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2019

Package DI Number

20854913006079

Quantity per Package

1

Contains DI Package

10854913006072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box