Catalog Number

10-0017

Brand Name

TACTICAL CricKIT

Version/Model Number

10-0017

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

K042684

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

a149a1a4-9f0b-411e-b387-0811fed0d01d

Public Version Date

March 15, 2022

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-