| Primary Device ID | 04953170195167 |
| NIH Device Record Key | 6ca1cb41-2250-4e2c-8b6e-78ed7f917f29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OLYMPUS EndoTherapy™ Inflation Device for Biliary |
| Version Model Number | QL® 2015 |
| Catalog Number | MAJ-1381 |
| Company DUNS | 047571476 |
| Company Name | ATRION MEDICAL PRODUCTS, INC. |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com | |
| Phone | +1(800)343-9334 |
| info@atrionmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170195167 [Primary] |
| KOE | Dilator, Urethral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2016-09-22 |
| 00856877002742 - QL Locking Syringe Device | 2025-05-26 Locking Syringe Device Atrion Part Number 96527: 38mL |
| 00856877002759 - QL Disposable Inflation Device | 2025-05-26 Inflation Device Atrion Part Number 96529: 25mL, 30atm |
| 00856877002766 - Atrion QL4515 Inflation Device | 2025-05-26 Inflation Device Atrion Part Number 96530: 45mL, 15atm |
| 00856877002773 - Atrion QL4515 Inflation Device | 2025-05-26 Inflation Device Atrion Part Number 96531: 45mL, 15atm |
| 00856877002704 - Atrion QL4515 Inflation Device | 2024-08-14 Inflation Device Atrion Part Number 96518: 45mL, 15atm |
| 00856877002735 - QL Inflation Device | 2024-08-14 Inflation Device: 60mL, 20atm |
| 00856877002728 - QL Disposable Inflation Device | 2022-11-15 Inflation Device: 40mL, 15atm |
| 00856877002711 - PAVmed™ Inflation Device | 2021-12-07 Inflation Device Atrion Part Number 96519: 40mL, 15atm |