Catalog Number

FH1600

Brand Name

DISPETTE®

Version/Model Number

FH1600

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JPH

Product Code Name

Test, Erythrocyte Sedimentation Rate

Public Device Record Key

2514317f-6fd6-4e11-bdb3-b023a4fc0dcc

Public Version Date

October 20, 2021

Public Version Number

2

DI Record Publish Date

November 07, 2019

Package DI Number

07612964013311

Quantity per Package

10

Contains DI Package

07612964013304

Package Discontinue Date

June 30, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE