Ever ONE - Berman airway is used to establish the airway and - XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Duns Number:543482946

Device Description: Berman airway is used to establish the airway and prevent the tongue fall and the airway b Berman airway is used to establish the airway and prevent the tongue fall and the airway block.

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More Product Details

Catalog Number

-

Brand Name

Ever ONE

Version/Model Number

S40/S60/S80/S90/S100/S110

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)

-

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

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

ad54901d-c343-4878-948b-ac1259c9173a

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Additional Identifiers

Package DI Number

16946430403763

Quantity per Package

100

Contains DI Package

06946430403766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"XIAMEN COMPOWER MEDICAL TECH. CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 27