Medis - Endotracheal Tube,Standard, Oral/Nasal with HVLP - Tianjin Medis Medical Device Co.,Ltd.

Duns Number:529125266

Device Description: Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 9.0

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More Product Details

Catalog Number

ETT-P22-90

Brand Name

Medis

Version/Model Number

ETT-P22-90

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K160694,K160694,K160694

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

a9397f2f-a432-46ae-8651-3c151055dc09

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 11, 2020

Additional Identifiers

Package DI Number

16920687301027

Quantity per Package

10

Contains DI Package

06920687301020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box