Mallinckrodt - Oral/Nasal Tracheal Tube Cuffed,Reinforced, - Covidien LP

Duns Number:058614483

Device Description: Oral/Nasal Tracheal Tube Cuffed,Reinforced, Murphy Eye

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More Product Details

Catalog Number

-

Brand Name

Mallinckrodt

Version/Model Number

86549

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

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

K790575,K790575

Product Code Details

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

58b920cf-9782-46b4-926d-e1d998ae45f4

Public Version Date

February 17, 2022

Public Version Number

4

DI Record Publish Date

August 30, 2015

Additional Identifiers

Package DI Number

20884522043349

Quantity per Package

5

Contains DI Package

10884522043342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40