Catalog Number

-

Brand Name

Thermo Scientific GlucoCrush™

Version/Model Number

B2495-6A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032753,K032753,K032753

Product Code

MRV

Product Code Name

Drink, Glucose Tolerance

Public Device Record Key

f5651cf7-2cd1-4b8d-996e-23ad0d1f172b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

00845275006780

Quantity per Package

4

Contains DI Package

00845275006605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-