| Primary Device ID | 50833224005125 |
| NIH Device Record Key | d29bacf4-516a-46ac-b294-bac07742ae54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bongo Rx |
| Version Model Number | BNG512 |
| Catalog Number | BNG512 |
| Company DUNS | 115178777 |
| Company Name | AirAvant Medical |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-925-2526 |
| info@airavant.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10833224005127 [Primary] |
| GS1 | 50833224005125 [Package] Contains: 10833224005127 Package: Master Carton [32 Units] In Commercial Distribution |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-18 |
| Device Publish Date | 2019-04-10 |
| 50833224005156 | Bongo Rx - XL - 1 Pack |
| 50833224005149 | Bongo Rx - LG - 1 Pack |
| 50833224005132 | Bongo Rx - MD - 1 Pack |
| 50833224005125 | Bongo Rx - SM - 1 Pack |
| 50833224005057 | Bongo Rx - XL - 4 Pack |
| 50833224005040 | Bongo Rx - LG - 4 Pack |
| 50833224005033 | Bongo Rx - MD - 4 Pack |
| 50833224005026 | Bongo Rx - SM - 4 Pack |
| 50833224005002 | Bongo Rx - All Sizes Kit (includes 1 each of sizes SM, MD, LG, and XL) |