JUMPER - Pulse oximeter (Color OLED display, - Shenzhen Jumper Medical Equipment Co.,Ltd.

Duns Number:529217911

Device Description: Pulse oximeter (Color OLED display, Unidirectional display)

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More Product Details

Catalog Number

-

Brand Name

JUMPER

Version/Model Number

JPD-500F

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

K170965

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

85d1d059-a195-4437-b3c6-5e817f98b44d

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 03, 2021

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