AV1016-01 Avoset 250mL Medication Reservoir Pouch AV1016-01

GUDID 17290109152704

250mL Medication Reservoir

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use
Primary Device ID17290109152704
NIH Device Record Key096a41b0-0d62-4dd3-9495-7070bfe76bc4
Commercial Distribution Discontinuation2025-08-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAV1016-01 Avoset 250mL Medication Reservoir Pouch
Version Model Number12222-000-1016
Catalog NumberAV1016-01
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109152704 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-08
Device Publish Date2025-08-31

Devices Manufactured by EITAN MEDICAL LTD

17290109152704 - AV1016-01 Avoset 250mL Medication Reservoir Pouch2025-09-08250mL Medication Reservoir
17290109152704 - AV1016-01 Avoset 250mL Medication Reservoir Pouch2025-09-08 250mL Medication Reservoir
27290109152640 - AV1010-01 Minibore Extension Set2025-06-06 MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
27290109152749 - Avoset Kit - US2025-03-13 Avoset kit
27290109155214 - AP209-012025-03-13 Spiral set
27290109155870 - AP414-012025-02-18 Administration set
27290109152688 - AV1017-01 Avoset 50ML Medication Reservoir2025-02-11
27290109155887 - AP434-012025-02-04
07290109155296 - Sapphire PCA Lockbox 500mL Label 2024-12-09

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