GoodKnight - GoodKnight H2O is a heated humidifier designed to - SEFAM

Duns Number:262411625

Device Description: GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnig GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series.

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More Product Details

Catalog Number

M-114600

Brand Name

GoodKnight

Version/Model Number

GoodKnight H2O

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)

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Device Record Status

Public Device Record Key

a531cfff-8348-40d0-9604-ac5dfdd5d163

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEFAM" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20