Mallinckrodt - Hi-Lo Oral/Nasal Tracheal Tube - Covidien LP

Duns Number:058614483

Device Description: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye

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More Product Details

Catalog Number

-

Brand Name

Mallinckrodt

Version/Model Number

86445

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

K965132,K965132,K965132

Product Code Details

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

dcd14d7c-0e7d-4db4-ba0e-328cb46589d6

Public Version Date

June 22, 2022

Public Version Number

6

DI Record Publish Date

August 30, 2015

Additional Identifiers

Package DI Number

50884522005713

Quantity per Package

10

Contains DI Package

40884522005716

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