Vive Presicion - Pulse Oximeter White - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Pulse Oximeter White

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More Product Details

Catalog Number

-

Brand Name

Vive Presicion

Version/Model Number

DMD1028WHT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

27948e10-7dec-471b-b6f6-c8ca4f163a41

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

November 15, 2017

Additional Identifiers

Package DI Number

20818323021596

Quantity per Package

100

Contains DI Package

10818323021599

Package Discontinue Date

July 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"VIVE HEALTH LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 87