Catalog Number

K617-029

Brand Name

OTS - Active Shooter

Version/Model Number

K617-029

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K960587,K945002,K940358,K940348,K940249

Product Code

CBP

Product Code Name

Valve, non-rebreathing

Public Device Record Key

54e75538-e353-4f5a-acc9-37d6e6cf5c91

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

May 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-