Demax - Beijing Demax Medical Technology Co., Ltd.

Duns Number:529725666

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More Product Details

Catalog Number

-

Brand Name

Demax

Version/Model Number

DPD20/OFF

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"

Yes

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

K140943,K140943

Product Code Details

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Device Record Status

Public Device Record Key

1c887c15-dd65-4f34-9f05-45374dd0aba5

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

August 09, 2019

Additional Identifiers

Package DI Number

16943718223082

Quantity per Package

20

Contains DI Package

06943718223085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62