Catalog Number

AC2000400

Brand Name

Itamar Snoring + BP for Watch-PAT 200S-3 and Watch-PAT200U

Version/Model Number

Itamar Snoring + BP for Watch-PAT 200S-3 and 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

-

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

e9f738b9-5ebf-489d-8fc8-f4b4efb2b663

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-