VALVEVAULT™ 081025

GUDID 00850012846055

VALVEVAULT™ DEVICE (S) 19mm / 21mm

LSI Solutions, Inc.

Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable
Primary Device ID00850012846055
NIH Device Record Key7a4c8c61-a9de-4562-a17e-5604ecba677d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVALVEVAULT™
Version Model Number081025
Catalog Number081025
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012846055 [Primary]

FDA Product Code

DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


[00850012846055]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-29

On-Brand Devices [VALVEVAULT™]

00850012846086VALVEVAULT™ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVI
00850012846079VALVEVAULT™ DEVICE (L) 27mm / 29mm
00850012846062VALVEVAULT™ DEVICE (M) 23mm / 25mm
00850012846055VALVEVAULT™ DEVICE (S) 19mm / 21mm

Trademark Results [VALVEVAULT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VALVEVAULT
VALVEVAULT
88947444 not registered Live/Pending
LSI Solutions, Inc.
2020-06-04

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