eitanmedical.comAvoset Infusion Pump System
Eitan Medical , Ltd.
Eitan Medical LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010293992 | 3010293992 | Eitan Medical LTD | 1 | N | 2026-01-01 | 29 Yad Haruzim St. Netanya Central IL 4250529 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 17290109152742 | Avoset Kit - US - Avoset kit | 949.288.5482 | customerservice@eitanmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164304 | 1130939585 | K213744 | Avoset Infusion Pump System | FRN | 2023-03-10 |
| 164304 | 1716734642 | K192860 | Sapphire Infusion Pump, Sapphire administration sets | FRN | 2020-11-19 |
| 164304 | 1223539975 | K161667 | Sapphire Infusion Pump | FRN | 2017-03-27 |
| 164304 | 1108556319 | K141834 | SAPPHIRE ADMINISTRATION SET | FPA | 2014-08-05 |
| 164304 | 1063991047 | K141389 | SAPPHIRE INFUSION PUMP | FRN | 2014-12-11 |
| 164304 | 1317699796 | K123049 | SAPPHIRE INFUSION PUMP | FRN | 2013-10-17 |
Product Codes Associated With Registrations#
PMN#
GUDID#
AP504-01 - UV RESISTANT INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, ROLLER CLAMP, FX ADMINISTRATION CASSETTE, NEEDLELESS Y-SITE AND SPIN MALE LUER LOCK
2026-05-07
AP433-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CASSETTE, ROLLER CLAMP, NEEDLELESS Y-SITE AND SPIN MALE LUER LOCK
2026-05-05
AV1029-01 Avoset Microbore set 12222-000-1029 - MICROBORE INFUSION SET WITH FEMALE LUER LOCK, SLIDE CLAMP, NEEDLELESS Y-SITE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, DSPR, AND MALE LUER LOCK WITH BACK CHECK VALVE
2026-04-14
AV1027-01 Avoset Microbore set 12222-000-1027 - MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, DSPR, AND MALE LUER LOCK WITH BACK CHECK VALVE.
2026-04-14
AV1016-01 Avoset 250mL Medication Reservoir Pouch - 250mL Medication Reservoir
2025-08-31
AV1010-01 Minibore Extension Set - MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
2025-05-29
AV1010-01 Minibore Extension Set - MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
2025-05-29
Avoset Kit - US - Avoset kit
2025-03-05
AP209-01 - Spiral set
2025-03-05
Avoset Kit - US - Avoset kit
2025-03-05
AP209-01 - Spiral set
2025-03-05
AP414-01 - Administration set
2025-02-10
AP414-01 - Administration set
2025-02-10
AV1017-01 Avoset 50ML Medication Reservoir - 12222-000-1017
2025-02-03
AV1017-01 Avoset 50ML Medication Reservoir - 12222-000-1017
2025-02-03
AP434-01 - 12000-000-0030
2025-01-27
AP434-01 - 12000-000-0030
2025-01-27
AP426-01 - NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK
2024-11-30
Sapphire PCA Lockbox 500mL Label - 15062-131-0010
2024-11-29
AP426-01 - NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK
2024-11-30
Eitan Medical - 100 mL MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED
2024-11-19
Sapphire M.T. Pump Kit C - 17000-028-1045
2024-09-04
Sapphire M.T. Pump Kit C - 17000-028-1045
2024-09-04
50/100 Avoset Pouch - 16043-010-1001
2024-07-23
Avoset Pouch Pro - 16044-010-1000
2024-07-23
50/100 Avoset Pouch - 16043-010-1001
2024-07-23
Avoset Pouch Pro - 16044-010-1000
2024-07-23
AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector - MICROBORE (YELLOW STRIPED) INFUSION SET WITH NON-VENTED SPIKE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, VENTED 0.2 um FILTER, BACK CHECK VALVE, NRFit CONNECTOR.
2024-07-18
AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector - MICROBORE (YELLOW STRIPED) INFUSION SET WITH NON-VENTED SPIKE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, VENTED 0.2 um FILTER, BACK CHECK VALVE, NRFit CONNECTOR.
2024-07-18
PCA Lockbox 250 Strap and Pouch - 15063-000-0004
2024-03-19
PCA Lockbox 250 Strap and Pouch - 15063-000-0004
2024-03-19
Sapphire Epidural Infusion Kit - US - 17000-031-1040
2023-09-05
Travel Case - 15020-010-0002
2024-03-03
Travel Case - 15020-010-0002
2024-03-03
Sapphire MT Infusion Kit 16 – US - 17000-028-1039
2024-02-25
Avoset Cartridge Set - 100 ML MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED.
2023-12-31
Avoset Cartridge Set - 100 ML MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED.
2023-12-31
Avoset Subcutaneous set - 12222-000-0013
2023-08-09
AP411-01 - 12003-000-0078
2023-09-05
Sapphire Power Supply - US - 15072-000-0007
2023-09-05