Catalog Number

AC-MT

Brand Name

NAPA

Version/Model Number

Sample Line Kit

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"

Yes

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

K172284,K172284

Product Code

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Public Device Record Key

d097a509-fbe8-4476-9edb-9148bd5fbff4

Public Version Date

January 03, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2018

Package DI Number

10860898002633

Quantity per Package

25

Contains DI Package

00860898002636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box