| Primary Device ID | 14953170058858 |
| NIH Device Record Key | e3243711-5963-4c37-a678-d688f60ab7dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BALLOON3 |
| Version Model Number | MAJ-236 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170058851 [Primary] |
| GS1 | 14953170058858 [Package] Contains: 04953170058851 Package: [20 Units] In Commercial Distribution |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-12 |
| 04953170360442 | MAJ-249 |
| 04953170360435 | MAJ-236 |
| 04953170360428 | MAJ-233 |
| 14953170058889 | MAJ-249 |
| 14953170058858 | MAJ-236 |
| 14953170058780 | MAJ-233 |