| Primary Device ID | 04035479181536 |
| NIH Device Record Key | 490267c5-498a-41ca-b14a-49a1a4976915 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEO |
| Version Model Number | 2301.U |
| Catalog Number | 478649 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | false |
| Manufacturing Date | false |
| 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 | 04035479181536 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-27 |
| Device Publish Date | 2023-04-19 |
| 04035479174781 | 2100.U |
| 04035479178017 | 2201.U/1 |
| 04035479181536 | 2301.U |
| 04035479179625 | 2204.U |
| 04035479184285 | 2303.U |
| 04035479186005 | 2401.U |