| Primary Device ID | 08033178111959 |
| NIH Device Record Key | c8c8dd58-2b27-4088-93d0-c234db34edb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inspire |
| Version Model Number | Bracket |
| Company DUNS | 442126587 |
| Company Name | SORIN GROUP ITALIA SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 08033178111959 [Primary] |
| KRI | ACCESSORY EQUIPMENT, 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 | 2023-11-01 |
| Device Publish Date | 2023-10-24 |
| 38033178113237 | 7 DUAL |
| 38033178113213 | 7 |
| 38033178113183 | 7 M |
| 38033178113015 | SVR 1200 |
| 38033178112421 | 8F DUAL PH.I.S.I.O. |
| 38033178112414 | 6F DUAL PH.I.S.I.O. |
| 38033178112407 | 8 DUAL PH.I.S.I.O. |
| 38033178112391 | 6 DUAL PH.I.S.I.O. |
| 38033178112384 | 8F PH.I.S.I.O. |
| 38033178112377 | 6F PH.I.S.I.O. |
| 38033178112360 | 8 PH.I.S.I.O. |
| 38033178112353 | 6 PH.I.S.I.O. |
| 38033178112308 | HVR DUAL |
| 38033178112292 | HVR |
| 38033178112285 | 8F M |
| 38033178112278 | 6F M |
| 38033178112261 | 8M |
| 38033178112254 | 6M |
| 38033178113367 | 7F DUAL |
| 38033178113350 | 7F |
| 38033178113343 | 7F M |
| 08033178112994 | Bracket |
| 08033178112987 | Bracket 1200 |
| 08033178112970 | Bracket |
| 08033178111966 | Bracket |
| 08033178111959 | Bracket |