| Primary Device ID | 27290109155283 |
| NIH Device Record Key | fd5946dd-113d-4a37-8098-3ce65b5a5c87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AP426-01 |
| Version Model Number | 12003-000-0025 |
| Company DUNS | 533108028 |
| Company Name | EITAN MEDICAL 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17290109155286 [Primary] |
| GS1 | 27290109155283 [Package] Contains: 17290109155286 Package: [30 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-09 |
| Device Publish Date | 2024-11-30 |
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| 27290109152749 - Avoset Kit - US | 2025-03-13 Avoset kit |
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| 27290109155870 - AP414-01 | 2025-02-18 Administration set |
| 27290109152688 - AV1017-01 Avoset 50ML Medication Reservoir | 2025-02-11 |
| 27290109155887 - AP434-01 | 2025-02-04 |
| 07290109155296 - Sapphire PCA Lockbox 500mL Label | 2024-12-09 |