Beluga1
GUDID 00860001239348
Beluga1 Imaging Probe
Tissue Differentiation Intelligence LLC
Surgical ultrasound imaging transducer| Primary Device ID | 00860001239348 |
| NIH Device Record Key | 75998864-3e1b-4ebb-b99d-bdc3af3d8109 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Beluga1 |
| Version Model Number | 100005 |
| Company DUNS | 081327336 |
| Company Name | Tissue Differentiation Intelligence LLC |
| 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 | 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 |
Customer Support Contacts
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com | |
| Phone | 305-351-2011 |
| customerservice@tissueintel.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 101 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001239348 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192388
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
[00860001239348]
Hydrogen Peroxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-11 |
| Device Publish Date | 2022-03-03 |
Devices Manufactured by Tissue Differentiation Intelligence LLC
| 00860001239300 - SonoVision | 2022-11-11 SonoVision Accessory Kit |
| 00860001239348 - Beluga1 | 2022-03-11Beluga1 Imaging Probe |
| 00860001239348 - Beluga1 | 2022-03-11 Beluga1 Imaging Probe |
| 00860001239355 - SonoVision | 2022-03-11 SonoVision Ultrasound Imaging Console |
Trademark Results [Beluga1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BELUGA1 90870785 not registered Live/Pending |
Tissue Differentiation Intelligence, LLC 2021-08-07 |
 BELUGA1 88243433 not registered Live/Pending |
Tissue Differentiation Intelligence, LLC 2018-12-27 |
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