Catalog Number

AC2101300

Brand Name

12 uPAT Probes for Watch-PAT

Version/Model Number

12 uPAT Probes for Watch-PAT

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

K133859,K153070,K161579,K180775

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

33b1c97b-b6dc-49bd-8698-4c36745ee5af

Public Version Date

June 26, 2019

Public Version Number

1

DI Record Publish Date

June 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-