Respironics - LoFlo CO2 Sampling O2 Delivery Cannula - Respironics Novametrix, LLC

Duns Number:093608594

Device Description: LoFlo CO2 Sampling O2 Delivery Cannula w/Dehumidification Tubing INFANT/NEONATAL NASAL

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More Product Details

Catalog Number

1149476

Brand Name

Respironics

Version/Model Number

1149476

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

-

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

e2f4d1b4-82ae-43b7-ab5d-7e18ee16b8f3

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS NOVAMETRIX, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 61