Shiley - Pediatric Tracheostomy Tube with TaperGuard Cuff - Covidien LP

Duns Number:058614483

Device Description: Pediatric Tracheostomy Tube with TaperGuard Cuff

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More Product Details

Catalog Number

-

Brand Name

Shiley

Version/Model Number

5.0PCF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K182861,K182861

Product Code Details

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Device Record Status

Public Device Record Key

82adbcd1-641b-4157-893d-919180561f87

Public Version Date

April 19, 2022

Public Version Number

4

DI Record Publish Date

May 16, 2019

Additional Identifiers

Package DI Number

10884521779723

Quantity per Package

48

Contains DI Package

20884521779720

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