EZ Trach Tie - EZ Trach Tie, Blue, Small - DYNAREX CORPORATION

Duns Number:008124539

Device Description: EZ Trach Tie, Blue, Small

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More Product Details

Catalog Number

-

Brand Name

EZ Trach Tie

Version/Model Number

4614

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Device Record Status

Public Device Record Key

8fdd2955-68a0-4417-a342-53fdf89a49a1

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Additional Identifiers

Package DI Number

00616784461434

Quantity per Package

60

Contains DI Package

00616784461410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2