AP417-01

GUDID 27290109154804

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use

• Primary Device ID: 27290109154804
• NIH Device Record Key: 6704e2f9-af21-4b87-9495-33d7f84856b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP417-01
• Version Model Number: 12004-000-0022
• Company DUNS: 533108028
• Company Name: EITAN MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109154807 [Primary]
GS1	27290109154804 [Package]; Contains: 17290109154807; Package: [30 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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-09-05

Devices Manufactured by EITAN MEDICAL LTD

• 27290109152749 - Avoset Kit - US: 2025-03-13 Avoset kit
• 27290109155214 - AP209-01: 2025-03-13 Spiral 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