Catalog Number

HB-1M

Brand Name

HemoBand

Version/Model Number

HB-1M

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K920614

Product Code

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

afc82cd5-11bb-4cd0-96ac-5e6c7a323859

Public Version Date

October 22, 2020

Public Version Number

3

DI Record Publish Date

September 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-