| Primary Device ID | 10827002462837 |
| NIH Device Record Key | 1fcc1439-728a-4c3d-b14e-d665a47b4da2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COOK Medical Sphere™ Inflation Device |
| Version Model Number | QL® 2515 |
| Catalog Number | CID-25-15 |
| 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 | |
| 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 | 00827002462830 [Primary] |
| GS1 | 10827002462837 [Package] Contains: 00827002462830 Package: [1 Units] In Commercial Distribution |
| MAV | Syringe, Balloon Inflation |
| 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 | 2016-09-21 |
| 10827002496740 | Inflation Device: 40mL, 15atm |
| 10827002462837 | Inflation Device: 25mL, 15atm |
| 10827002349039 | Inflation Device: 60mL, 15atm |
| 10827002310275 | Inflation Device: 20mL, 30atm |
| 10827002255712 | Inflation Device: 20mL, 30atm |