VALVEVAULT™ - VALVEVAULT™ DEVICE KITThis kit includes one (1) - LSI Solutions, Inc.

Duns Number:603420183

Device Description: VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEV VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.

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More Product Details

Catalog Number

081040

Brand Name

VALVEVAULT™

Version/Model Number

081040

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Record Status

Public Device Record Key

916439cb-025e-40d5-9816-1c7c94f55632

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LSI SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 31