Catalog Number

AC2110800

Brand Name

WatchPATONE

Version/Model Number

WatchPATONE

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,K183559,K183559

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

a468e373-125b-4a52-a097-416844d4db05

Public Version Date

May 13, 2020

Public Version Number

4

DI Record Publish Date

June 30, 2019

Package DI Number

07290109222431

Quantity per Package

12

Contains DI Package

07290109222424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton