Catalog Number

SA-3000P

Brand Name

SA-3000P

Version/Model Number

SA-3000P

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073323,K073323

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Public Device Record Key

3be4ad50-16ea-48c1-a9da-e9d0fb126b11

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Package DI Number

10191237000011

Quantity per Package

1

Contains DI Package

00191237000014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton