Catalog Number

-

Brand Name

BELTER

Version/Model Number

PA-52

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K134029,K134029,K134029

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

d2af9349-c0e9-4770-9253-2781f84a4092

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

16947468500080

Quantity per Package

1

Contains DI Package

06947468500281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX