VIVE - Shampoo Basin Blue - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Shampoo Basin Blue

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More Product Details

Catalog Number

-

Brand Name

VIVE

Version/Model Number

LVA2044

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILS

Product Code Name

Adaptor, Hygiene

Device Record Status

Public Device Record Key

d01e4a80-a6df-432c-91c7-b899d58722d6

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

March 19, 2020

Additional Identifiers

Package DI Number

10810041981681

Quantity per Package

1

Contains DI Package

00810041981684

Package Discontinue Date

-

Package Status

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