Catalog Number

ABG-HM-1

Brand Name

Hummi Micro-Draw

Version/Model Number

ABG-HM-1

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"

Yes

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

KST

Product Code Name

System, Blood Collection, Vacuum-Assisted, Manual

Public Device Record Key

e31b36f9-47c6-444c-9921-fdf021867e2e

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Package DI Number

20817522013302

Quantity per Package

50

Contains DI Package

10817522013305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box