Vital Signs - Vital Signs® Tracheal Tube Oral/Nasal - Carefusion Corporation

Duns Number:830432451

Device Description: Vital Signs® Tracheal Tube Oral/Nasal

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More Product Details

Catalog Number

8055UC

Brand Name

Vital Signs

Version/Model Number

8055UC

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"

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

K042683,K042683,K042683,K042683

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

8edfaad8-066b-41d7-9deb-9cfc4de9b9ea

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

August 29, 2016

Additional Identifiers

Package DI Number

50885403295988

Quantity per Package

4

Contains DI Package

20885403295987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"CAREFUSION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 876
3 A medical device with high risk that requires premarket approval 29