Catalog Number

AC2000110

Brand Name

12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, Watch-PAT200U

Version/Model Number

12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, 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

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

-

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

3c565aff-2634-4fc6-bb5a-1a2876b47361

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-