AP411-01

GUDID 27290109154590

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 27290109154590
• NIH Device Record Key: ed210149-d0c9-43ae-8e65-3300d466cdef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP411-01
• Version Model Number: 12003-000-0078
• 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: false
• 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	17290109154593 [Primary]
GS1	27290109154590 [Package]; Contains: 17290109154593; 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

• 27290109151650 - PCA Lockbox 250 Strap and Pouch: 2024-03-27
• 27290109154101 - Travel Case: 2024-03-11
• 17290109155095 - Sapphire MT Infusion Kit 16 – US: 2024-03-04
• 27290109152565 - Avoset Cartridge Set: 2024-01-08 100 ML MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED.
• 27290109154705 - Sapphire Power Supply - US: 2023-09-13
• 27290109154590 - AP411-01: 2023-09-13
• 27290109154590 - AP411-01: 2023-09-13
• 27290109154804 - AP417-01: 2023-09-13
• 27290109155115 - AP402-01: 2023-09-13