| Primary Device ID | 00856877002704 |
| NIH Device Record Key | aa5aa1f8-5695-42b4-9532-0aa88cc67d1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atrion QL4515 Inflation Device |
| Version Model Number | QL4515 |
| Catalog Number | 96518 |
| 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 | 00856877002704 [Primary] |
| KOE | Dilator, Urethral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
| 00856877002704 | Inflation Device Atrion Part Number 96518: 45mL, 15atm |
| 00856877002773 | Inflation Device Atrion Part Number 96531: 45mL, 15atm |
| 00856877002766 | Inflation Device Atrion Part Number 96530: 45mL, 15atm |