AP414-01

GUDID 27290109155870

Administration set

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use

• Primary Device ID: 27290109155870
• NIH Device Record Key: ec168647-e399-41f7-b8e1-e43324ae6dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP414-01
• Version Model Number: 12003-000-0021
• Company DUNS: 533108028
• Company Name: EITAN MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109155873 [Primary]
GS1	27290109155870 [Package]; Contains: 17290109155873; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192860

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

[27290109155870]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-18
• Device Publish Date: 2025-02-10

Devices Manufactured by EITAN MEDICAL LTD

• 27290109155870 - AP414-01: 2025-02-18Administration set
• 27290109155870 - AP414-01: 2025-02-18 Administration set
• 27290109152688 - AV1017-01 Avoset 50ML Medication Reservoir: 2025-02-11
• 27290109155887 - AP434-01: 2025-02-04
• 07290109155296 - Sapphire PCA Lockbox 500mL Label: 2024-12-09
• 27290109155283 - AP426-01: 2024-12-09 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 C: 2024-09-12
• 27290109152619 - 50/100 Avoset Pouch: 2024-07-31