OBALON®
GUDID 00859810006197
OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
OBALON THERAPEUTICS, INC.
Gastrointestinal catheter/endoscope tracking system sensor, wearable| Primary Device ID | 00859810006197 |
| NIH Device Record Key | 6e6b9843-b8da-459c-b979-17d1a3efc9c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OBALON® |
| Version Model Number | 7404-0001 |
| Company DUNS | 022894714 |
| Company Name | OBALON THERAPEUTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859810006197 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160001
FDA Product Code
| LTI | Implant, Intragastric For Morbid Obesity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2019-02-20 |
On-Brand Devices [OBALON®]
| 00859810006241 | OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console |
| 00859810006234 | OBALON® Navigation Balloon Kit - Intragastric Balloon |
| 10859810006224 | OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON |
| 00859810006197 | OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console |
| 00859810006180 | OBALON® Navigation Console - component to visualize the OBALON® Balloon |
| 00859810006173 | OBALON® Balloon Evacuator - component for use with the OBALON® Balloon |
| 00859810006142 | OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon |
Trademark Results [OBALON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OBALON 77416644 4067456 Live/Registered |
Obalon Therapeutics, Inc. 2008-03-07 |
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