NomoLine-O LH Pediatric Nasal/Oral CO2 Cannula with O2 - Masimo Sweden AB

Duns Number:632369067

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More Product Details

Catalog Number

-

Brand Name

NomoLine-O LH Pediatric Nasal/Oral CO2 Cannula with O2

Version/Model Number

4460

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

bee28386-2810-4d7d-9189-e83801b842a7

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

June 27, 2019

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