| Primary Device ID | 00857863007321 |
| NIH Device Record Key | ba7b3e4d-49a1-430b-88fd-997ecf1bfebc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insta/Vent |
| Version Model Number | IV-600V |
| 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 | 00857863007130 [Primary] |
| GS1 | 00857863007321 [Package] Contains: 00857863007130 Package: Carton [6 Units] In Commercial Distribution |
| IYT | System, Rebreathing, Radionuclide |
| 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 |
| 00857863007925 | Replacement Elbow, 22mm OD x 22mm ID and Adapter Seal, .596" O.D. |
| 00857863007383 | Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and |
| 00857863007352 | Insta/Vent Portable Shield, Aluminum Case |
| 00857863007321 | Insta/Vent Ventilator Kit w/HEPA Filter - For ventilator dependent patients |
| 00857863007291 | Insta/Vent Radioaerosol Unit w/HEPA Filter & Mask |
| 00857863007284 | Insta/Vent Radioaerosol Unit w/Hepa Filter & Rigid Mouthpiece |
| 00857863007277 | Insta/Vent Radioaerosol Unit w/HEPA Filter |