Alice NightOne - Alice NightOne Home Diagnostic System, Masimo - Respironics, Inc.

Duns Number:080728314

Device Description: Alice NightOne Home Diagnostic System, Masimo oximetry, Wireless, North America

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More Product Details

Catalog Number

1133949

Brand Name

Alice NightOne

Version/Model Number

Alice NightOne System, Masimo, NA

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

-

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

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Device Record Status

Public Device Record Key

e21cf46d-62c1-49ee-8c85-6ba1c2032b37

Public Version Date

March 04, 2021

Public Version Number

4

DI Record Publish Date

June 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 151
2 A medical device with a moderate to high risk that requires special controls. 3279