Catalog Number

Max Pulse

Brand Name

Max Pulse

Version/Model Number

Max Pulse

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

K110374,K110374,K110374,K110374,K110374

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Public Device Record Key

da271aec-2c4e-4ebb-9c7d-515e491caea4

Public Version Date

March 13, 2019

Public Version Number

1

DI Record Publish Date

March 05, 2019

Package DI Number

40191237000036

Quantity per Package

20

Contains DI Package

10191237000035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton