| Primary Device ID | KG1240 |
| NIH Device Record Key | edbab3b1-4d1a-425f-b17b-0d699751aca6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aeris Balloon Dilation Catheter |
| Version Model Number | KG1240 |
| Company DUNS | 160067273 |
| Company Name | BRYAN MEDICAL, 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | KG1240 [Primary] |
| EOQ | Bronchoscope (Flexible Or Rigid) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-18 |
| KG1840 | Aeris Balloon Dilation Catheter 18x40mm |
| KG1640 | Aeris Balloon Dilation Catheter 16x40mm |
| KG1240 | Aeris Balloon Dilation Catheter 12x40mm |
| KG1030 | Aeris Balloon Dilation Catheter 10x30mm |
| KG0930 | Aeris Balloon Dilation Catheter 9x30mm |
| KG0830 | Aeris Balloon Dilation Catheter 8x30mm |
| KG0730 | Aeris Balloon Dilation Catheter 7x30mm |
| KG0630 | Aeris Balloon Dilation Catheter 6x30mm |
| KG0530 | Aeris Balloon Dilation Catheter 5x30mm |