Catalog Number

-

Brand Name

alpHaONE

Version/Model Number

JSPR-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 01, 2030

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FFT

Product Code Name

Electrode, Ph, Stomach

Public Device Record Key

3e4888a5-05ca-4a26-9aba-1493838c512d

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

16946332803159

Quantity per Package

4

Contains DI Package

06946332800649

Package Discontinue Date

August 01, 2030

Package Status

In Commercial Distribution

Package Type

-