Catalog Number

US2150306

Brand Name

Watch-PAT 200i

Version/Model Number

Watch-PAT 200i

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

K081037,K081037

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

6cdeae9f-cd72-48f2-9a90-7175d3253351

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

07290109222950

Quantity per Package

1

Contains DI Package

07290109222981

Package Discontinue Date

-

Package Status

-

Package Type

-