MedSource Sampling Cannula - 7’ Adult Nasal CO2 Sampling Cannula - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: 7’ Adult Nasal CO2 Sampling Cannula

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Sampling Cannula

Version/Model Number

MS-35400A7

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

K143127,K143127,K143127

Product Code Details

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

08be2940-6a27-49d5-b91f-c65c9d979215

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2022

Additional Identifiers

Package DI Number

00840155413078

Quantity per Package

25

Contains DI Package

00840155413061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90