AP426-01

GUDID 27290109155283

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

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use
Primary Device ID27290109155283
NIH Device Record Keyfd5946dd-113d-4a37-8098-3ce65b5a5c87
Commercial Distribution StatusIn Commercial Distribution
Brand NameAP426-01
Version Model Number12003-000-0025
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109155286 [Primary]
GS127290109155283 [Package]
Contains: 17290109155286
Package: [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-12-09
Device Publish Date2024-11-30

Devices Manufactured by EITAN MEDICAL LTD

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
27290109155283 - AP426-012024-12-09NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK
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

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