Catalog Number

AS2150500

Brand Name

Watch-PAT200U

Version/Model Number

Watch-PAT200U

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

K133859,K153070,K161579,K133859,K153070,K161579

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

67552ba8-1f30-4f38-a024-5c0799a36bbe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

07290109222523

Quantity per Package

1

Contains DI Package

07290109222639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-