| Primary Device ID | 17290117830069 |
| NIH Device Record Key | 137bb6b5-dc1f-4f8a-bb41-0e2722bf1cb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSPIRA ART100 |
| Version Model Number | INSPIRA ART100 Emergency Manual Pump Drive |
| Catalog Number | INS-010301 |
| Company DUNS | 531834876 |
| Company Name | INSPIRA TECHNOLOGIES OXY B.H.N LTD |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290117830062 [Primary] |
| GS1 | 17290117830069 [Package] Contains: 07290117830062 Package: [1 Units] In Commercial Distribution |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-10 |
| 17290117830144 | INSPIRA ART100 Flow Sensor 1/4"x1/16" |
| 07290117830116 | Packed INSPIRA ART100 System |
| 07290117830109 | INSPIRA ART100 Cables Set & Temperature Sensor |
| 17290117830090 | INSPIRA ART100 Flow Sensor 3/8"x3/32" |
| 07290117830086 | Packed INSPIRA ART100 Holders |
| 17290117830069 | INSPIRA ART100 Emergency Manual Pump Drive |
| 17290117830052 | INSPIRA ART100 Pump Drive |
| 07290117830048 | INSPIRA ART100 Controller |