| Primary Device ID | 20859810006269 |
| NIH Device Record Key | 1b12c782-29fc-48d4-ba76-96a5d30514bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Obalon Aspiration Adapter |
| Version Model Number | 6100-0004 |
| Company DUNS | 022894714 |
| Company Name | OBALON THERAPEUTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859810006265 [Primary] |
| GS1 | 10859810006262 [Package] Contains: 00859810006265 Package: [5 Units] In Commercial Distribution |
| GS1 | 20859810006269 [Package] Contains: 10859810006262 Package: [2 Units] In Commercial Distribution |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-08-09 |
| 00859810006197 - OBALON® | 2020-02-06 OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console |
| 20859810006269 - Obalon Aspiration Adapter | 2019-11-08Aspiration adapter |
| 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 |