Catalog Number

EP036

Brand Name

B&H

Version/Model Number

HTD2601US

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

fd3705fd-a1b1-479c-b491-43d72562d702

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

16970289035547

Quantity per Package

30

Contains DI Package

06970289035540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-