Fisher & Paykel Healthcare - Nivairo+ RT057 Vented Hospital Full Face Mask, - FISHER & PAYKEL HEALTHCARE LIMITED

Duns Number:590153276

Device Description: Nivairo+ RT057 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version- Large

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More Product Details

Catalog Number

RT057L

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

RT057L

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"

-

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

MNT

Product Code Name

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Device Record Status

Public Device Record Key

3a1db018-ffb5-496b-9499-6e2f8f7b853e

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Additional Identifiers

Package DI Number

09420012460806

Quantity per Package

10

Contains DI Package

09420012460790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK

"FISHER & PAYKEL HEALTHCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 159
2 A medical device with a moderate to high risk that requires special controls. 349