Merlyn EndoTube - 6.5mm ID preformed nasal cuffed endotracheal tube - MERLYN ASSOCIATES, INC.

Duns Number:606864184

Device Description: 6.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and s 6.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth Murphy tip

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More Product Details

Catalog Number

440065

Brand Name

Merlyn EndoTube

Version/Model Number

Preformed Nasal 440065

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)

Yes

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

K042683,K042683

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

fd766de1-4f58-46c6-8513-095bb0168a47

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 01, 2016

Additional Identifiers

Package DI Number

10182151000409

Quantity per Package

10

Contains DI Package

00182151000402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner carton

"MERLYN ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 54