BacT/ALERT®3D CONTROL MODULE
GUDID 03573026049522
The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one integrated touchscreen computer.
BIOMERIEUX , INC.
Blood culture analyser IVD, automated| Primary Device ID | 03573026049522 |
| NIH Device Record Key | a78087a5-fd05-4219-97f6-13c2ad073498 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BacT/ALERT®3D CONTROL MODULE |
| Version Model Number | 210147 |
| Company DUNS | 086785110 |
| Company Name | BIOMERIEUX , INC. |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026049522 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K903505
FDA Product Code
| MDB | System, blood culturing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-02 |
| Device Publish Date | 2020-10-23 |
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| 03573026635978 - VITEK® 2 AST-N809 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 03573026636142 - VITEK® 2 AST-N811 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 03573026636296 - VITEK® 2 AST-N812 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
Trademark Results [BacT/ALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BACT/ALERT 77523447 3962173 Live/Registered |
bioMérieux, Inc. 2008-07-16 |
 BACT/ALERT 75022103 2017525 Live/Registered |
BIOMERIEUX, INC. 1995-11-20 |
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