GLOBAL HEALTHCARE - ENDOTRACHEAL TUBE 7.5MM, CUFFED - GHC HEALTHCARE, INC.

Duns Number:884718776

Device Description: ENDOTRACHEAL TUBE 7.5MM, CUFFED

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More Product Details

Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

61-175

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K042683,K042683,K042683

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

7a011322-5762-4983-9553-725127389130

Public Version Date

August 06, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40872237002588

Quantity per Package

10

Contains DI Package

20872237002584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"GHC HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62