Catalog Number

US2110701

Brand Name

Watch-PAT300

Version/Model Number

Watch-PAT300

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180775,K180775

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

11d6eb8f-2f9f-4159-ae8d-942ebf273183

Public Version Date

August 28, 2019

Public Version Number

1

DI Record Publish Date

August 20, 2019

Package DI Number

07290109222486

Quantity per Package

1

Contains DI Package

07290109222479

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton