Catalog Number

-

Brand Name

alpHaONE

Version/Model Number

JSPC-1

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

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

-

Product Code

FFT

Product Code Name

Electrode, Ph, Stomach

Public Device Record Key

d410f2fd-1270-40da-b676-3c3ee4c4a50c

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

06946332800625

Quantity per Package

2

Contains DI Package

06946332800045

Package Discontinue Date

August 01, 2030

Package Status

In Commercial Distribution

Package Type

-