BELMINT - Shenzhen Jumper Medical Equipment Co.,Ltd.

Duns Number:529217911

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More Product Details

Catalog Number

-

Brand Name

BELMINT

Version/Model Number

JPD-100S

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

K110124

Product Code Details

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Device Record Status

Public Device Record Key

01b1f037-aa0e-4ecb-8afc-3f4e212e807a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN JUMPER MEDICAL EQUIPMENT CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 59