Endure - Endotracheal Tube, Preformed, Nasal, Cuffed, Size - ENDURE INDUSTRIES

Duns Number:066087031

Device Description: Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.5 mm internal diameter

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More Product Details

Catalog Number

ETPNC756

Brand Name

Endure

Version/Model Number

ETPNC7561017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K080105,K080105,K080105

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

3977b9cf-7cd1-43cd-8cf7-7f32d4986bd5

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 21, 2018

Additional Identifiers

Package DI Number

B531ETPNC7562

Quantity per Package

20

Contains DI Package

B531ETPNC7561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"ENDURE INDUSTRIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 36