DreamStation - DreamStation Wi-Fi Accessory China - Respironics, Inc.

Duns Number:080728314

Device Description: DreamStation Wi-Fi Accessory China

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More Product Details

Catalog Number

100765W

Brand Name

DreamStation

Version/Model Number

DreamStation Wi-Fi Accessory, CN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2021

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

b074024b-bbdd-4135-9de2-3c4b6b58034a

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

February 16, 2018

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