AV1017-01 Avoset 50ML Medication Reservoir

GUDID 27290109152688

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use
Primary Device ID27290109152688
NIH Device Record Key0ec85d43-077b-48d7-aeaa-99664d5aba11
Commercial Distribution StatusIn Commercial Distribution
Brand NameAV1017-01 Avoset 50ML Medication Reservoir
Version Model Number12222-000-1017
Company DUNS533108028
Company NameEITAN MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109152674 [Primary]
GS127290109152688 [Package]
Contains: 17290109152674
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


[27290109152688]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-11
Device Publish Date2025-02-03

Devices Manufactured by EITAN MEDICAL LTD

27290109155870 - AP414-012025-02-18 Administration set
27290109152688 - AV1017-01 Avoset 50ML Medication Reservoir2025-02-11
27290109152688 - AV1017-01 Avoset 50ML Medication Reservoir2025-02-11
27290109155887 - AP434-012025-02-04
07290109155296 - Sapphire PCA Lockbox 500mL Label 2024-12-09
27290109155283 - AP426-012024-12-09 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 C2024-09-12
27290109152619 - 50/100 Avoset Pouch2024-07-31

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.