AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector

GUDID 27290109152152

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.

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use
Primary Device ID27290109152152
NIH Device Record Keyd067ce6d-c851-4858-beae-3457953cf5ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector
Version Model Number12222-000-0003
Company DUNS533108028
Company NameEITAN MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS117290109152155 [Primary]
GS127290109152152 [Package]
Contains: 17290109152155
Package: [20 Units]
Discontinued: 2024-07-17
Not in Commercial Distribution

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 Date2024-07-26
Device Publish Date2024-07-18

Devices Manufactured by EITAN MEDICAL LTD

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
27290109152626 - Avoset Pouch Pro2024-07-31
27290109152152 - AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector2024-07-26MICROBORE (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.
27290109152152 - AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector2024-07-26 MICROBORE (YELLOW STRIPED) INFUSION SET WITH NON-VENTED SPIKE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, V
27290109151650 - PCA Lockbox 250 Strap and Pouch2024-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.