| Primary Device ID | 27290109155115 |
| NIH Device Record Key | e56762f2-7e77-4cb9-8634-77021ac4eab2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AP402-01 |
| Version Model Number | 12004-000-0004 |
| 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 | false |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17290109155118 [Primary] |
| GS1 | 27290109155115 [Package] Contains: 17290109155118 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 | 2023-09-13 |
| Device Publish Date | 2023-09-05 |
| 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 |
| 27290109155283 - AP426-01 | 2024-12-09 NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK |
| 17290109152728 - Eitan Medical | 2024-11-27 100 mL MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED |
| 27290109155306 - Sapphire M.T. Pump Kit C | 2024-09-12 |
| 27290109152619 - 50/100 Avoset Pouch | 2024-07-31 |