Fisher & Paykel Healthcare - Humidifier Mounting Tray - FISHER & PAYKEL HEALTHCARE LIMITED

Duns Number:590153276

Device Description: Humidifier Mounting Tray

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More Product Details

Catalog Number

900HC007

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

900HC007

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FOX

Product Code Name

Stand, Infusion

Device Record Status

Public Device Record Key

adf171a7-f489-46c5-a5f9-3954f19b44f3

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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