Beluga1
GUDID 00860001239348
Beluga1 Imaging Probe
Tissue Differentiation Intelligence LLC
Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer 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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