Catalog Number

H-003DS

Brand Name

Small D-Ring Arm Cuff for Digital Blood Pressure Monitor

Version/Model Number

H-003DS

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

K930798,K930798

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

7a3f948d-a03a-4c66-aa2b-2551dc8f894d

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796800366

Quantity per Package

50

Contains DI Package

00073796800369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case