Catalog Number

AMPET35W

Brand Name

Rospital Productos Medicos

Version/Model Number

AMPET35W

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

K190213,K190213,K190213

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

3b4ddcd7-6bb7-4a67-bc8a-cc10fc0fb5a8

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

10812460024109

Quantity per Package

25

Contains DI Package

00812460024102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX