VALVEVAULT™ 081040
GUDID 00850012846086
VALVEVAULT™ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.
LSI Solutions, Inc.
Heart valve prosthesis holder, reusable| Primary Device ID | 00850012846086 |
| NIH Device Record Key | 916439cb-025e-40d5-9816-1c7c94f55632 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VALVEVAULT™ |
| Version Model Number | 081040 |
| Catalog Number | 081040 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012846086 [Primary] |
FDA Product Code
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
[00850012846086]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-08 |
| Device Publish Date | 2021-01-29 |
On-Brand Devices [VALVEVAULT™]
| 00850012846086 | VALVEVAULT™ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVI |
| 00850012846079 | VALVEVAULT™ DEVICE (L) 27mm / 29mm |
| 00850012846062 | VALVEVAULT™ DEVICE (M) 23mm / 25mm |
| 00850012846055 | VALVEVAULT™ DEVICE (S) 19mm / 21mm |
Trademark Results [VALVEVAULT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VALVEVAULT 88947444 not registered Live/Pending |
LSI Solutions, Inc. 2020-06-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.