NomoLine-O™ LH Adult Nasal/Oral CO2 Cannula 4m - Masimo Sweden AB

Duns Number:632369067

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More Product Details

Catalog Number

-

Brand Name

NomoLine-O™ LH Adult Nasal/Oral CO2 Cannula 4m

Version/Model Number

4636

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

-

Product Code Details

Product Code

BYH

Product Code Name

Drain, Tee (Water Trap)

Device Record Status

Public Device Record Key

728a6d07-f721-4f46-9540-b1b4d7f65e30

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

January 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MASIMO SWEDEN AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 30