NV QUATTRO FX - NV QUATTRO FX FFM LGE - RESMED PTY LTD

Duns Number:751149311

Device Description: NV QUATTRO FX FFM LGE

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More Product Details

Catalog Number

61741

Brand Name

NV QUATTRO FX

Version/Model Number

61741

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

-

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

e45f49fc-5bf1-4017-b6db-23fe288c55de

Public Version Date

July 23, 2021

Public Version Number

5

DI Record Publish Date

September 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESMED PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54
2 A medical device with a moderate to high risk that requires special controls. 841