| Primary Device ID | 00857863007819 |
| NIH Device Record Key | 0f3b1cab-5829-4652-bd88-13ab2b56a5be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Healthline, ARK - Asthma Rescue Kit, Mix & Mount |
| Version Model Number | ARK-1 |
| Company DUNS | 079628327 |
| Company Name | Medi/Nuclear Corporation, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 800-321-5981 |
| cs@medinuclear.com |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857863007741 [Primary] |
| GS1 | 00857863007819 [Package] Contains: 00857863007741 Package: Carton [5 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-09 |
| 00857863007826 | Asthma Rescue Kit, Pediatric, Bacteria Filter, w/ Mix & Mount Body |
| 00857863007819 | Asthma Rescue Kit, Adult, Bacteria Filter, w/ Mix & Mount Body |