Catalog Number

AC2110860

Brand Name

WatchPAT ONE-M

Version/Model Number

WatchPAT ONE-M

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

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

K183559,K183559

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

a861d056-4be4-46d4-afdd-42ac9ae85242

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

07290109223049

Quantity per Package

12

Contains DI Package

07290109223032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton