Catalog Number

TKS105

Brand Name

Centurion

Version/Model Number

TKS105

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)

Yes

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

-

Product Code

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

1e869167-bbe5-46e0-879b-6445c8979e6d

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

00653160258516

Quantity per Package

50

Contains DI Package

10653160258513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE