Catalog Number

AMPET25W

Brand Name

Rospital Productos Medicos

Version/Model Number

AMPET25W

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"

Yes

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

K140228,K140228,K140228

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

9fa0f263-b2c1-4710-9457-bd8a0f447f7e

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 18, 2020

Package DI Number

10812460028671

Quantity per Package

10

Contains DI Package

00812460028674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CASE