pluse oximeter - Shenzhen Jumper Medical Equipment Co.,Ltd.

Duns Number:529217911

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More Product Details

Catalog Number

-

Brand Name

pluse oximeter

Version/Model Number

JPD-500C

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

K140582,K140582

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

3bee9e6a-aecf-4b97-bbe3-9a84425f26f2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

06951740500265

Quantity per Package

50

Contains DI Package

06951740500197

Package Discontinue Date

-

Package Status

In Commercial Distribution

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