Vive - Nosey Dysphagia Cup - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Nosey Dysphagia Cup

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More Product Details

Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA2099GRY

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

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

0f1faf0d-f7a3-45b2-a312-ae0eb7524b41

Public Version Date

December 02, 2021

Public Version Number

1

DI Record Publish Date

November 24, 2021

Additional Identifiers

Package DI Number

10810041988116

Quantity per Package

32

Contains DI Package

00810041988119

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