Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer) - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer)

Version/Model Number

NC-87500

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)

Yes

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

K143150

Product Code Details

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

4e9193ac-0052-463a-a8e4-54192a136734

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BESMED HEALTH BUSINESS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 217