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 |
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 | 2024-12-09NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK |
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 |