Charder - CHARDER ELECTRONIC CO., LTD.

Duns Number:656102035

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More Product Details

Catalog Number

-

Brand Name

Charder

Version/Model Number

MS5440TB

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRW

Product Code Name

Scale, Patient

Device Record Status

Public Device Record Key

65b5c62f-684b-4bf2-9222-e75c24cc3262

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

November 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHARDER ELECTRONIC CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 110
2 A medical device with a moderate to high risk that requires special controls. 35