Variolock
GUDID 04033817900191
LivaNova Deutschland GmbH
Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type| Primary Device ID | 04033817900191 |
| NIH Device Record Key | 6a7a3320-395f-4316-aa1e-b8a7cc6431eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Variolock |
| Version Model Number | Inserts Small |
| Company DUNS | 343225272 |
| Company Name | LivaNova Deutschland GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04033817900191 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071318
FDA Product Code
| DTQ | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2015-10-14 |
On-Brand Devices [Variolock]
| 04033817901976 | Insert Cardioplegia 1:1 |
| 04033817901563 | Inserts Cardioplegia 1:4 |
| 04033817900399 | Tubing Clamp RP150 |
| 04033817900238 | Inserts Cardioplegia 4:1 |
| 04033817900221 | Inserts Cardioplegia 4:1 |
| 04033817900214 | Inserts Cardioplegia 2:1 |
| 04033817900207 | Inserts Cardioplegia 1:1 |
| 04033817900191 | Inserts Small |
| 04033817900184 | Inserts Large |
Trademark Results [Variolock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIOLOCK 79017351 not registered Dead/Abandoned |
Lehnhoff Hartstahl GmbH & Co. 2004-09-10 |
 VARIOLOCK 76422923 2793923 Dead/Cancelled |
Koninklijke Philips Electronics N.V. 2002-06-19 |
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