Catalog Number

-

Brand Name

Allheart

Version/Model Number

HS-50B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

0f66b347-e725-49b1-85ae-e0d2385e1d0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-