Catalog Number

-

Brand Name

Thopaz Tubing Extension, 1 Line, sterile

Version/Model Number

101039326

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141553,K141553

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

3f32fe8c-cd3d-4966-aa41-82f32194a156

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Package DI Number

07612367078108

Quantity per Package

15

Contains DI Package

07612367078115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-