OBALON® Balloon System
GUDID 10859810006057
OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit
OBALON THERAPEUTICS, INC.
Appetite-suppression gastric balloon| Primary Device ID | 10859810006057 |
| NIH Device Record Key | d6161536-099c-42f8-a781-08cbb9e502fb |
| Commercial Distribution Discontinuation | 2017-07-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | OBALON® Balloon System |
| Version Model Number | 9500-0001 |
| Company DUNS | 022894714 |
| Company Name | OBALON THERAPEUTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859810006050 [Primary] |
| GS1 | 10859810006057 [Package] Contains: 00859810006050 Package: [5 Units] Discontinued: 2017-07-12 Not in Commercial Distribution |
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 | 5 |
| Public Version Date | 2018-07-12 |
| Device Publish Date | 2016-12-26 |
Devices Manufactured by OBALON THERAPEUTICS, INC.
| 00859810006197 - OBALON® | 2020-02-06 OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console |
| 20859810006269 - Obalon Aspiration Adapter | 2019-11-08 Aspiration adapter |
| 00859810006104 - OBALON Touch™ | 2019-03-11 OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon |
| 00859810006142 - OBALON® | 2019-03-11 OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon |
| 00859810006173 - OBALON® | 2019-03-11 OBALON® Balloon Evacuator - component for use with the OBALON® Balloon |
| 00859810006180 - OBALON® | 2019-03-11 OBALON® Navigation Console - component to visualize the OBALON® Balloon |
| 00859810006203 - OBALON Touch™ | 2019-03-11 OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batte |
| 10859810006224 - OBALON® | 2019-03-11 OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors |
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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