Catalog Number

S0001-5

Brand Name

Safe T Check

Version/Model Number

Safe T Check

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

c23a5198-0fad-4625-92f8-edfeab449784

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Package DI Number

B279S00012

Quantity per Package

600

Contains DI Package

B279S00015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

2