AP424-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE

GUDID 27290109154880

MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP, BACK CHECK VALVE, Y-SITE AND SPIN MALE LUER LOCK, AND WITH FEMALE LUER LOCK, SLIDE CLAMP AND A BACK CHECK VALV

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use

• Primary Device ID: 27290109154880
• NIH Device Record Key: 45f752e3-d10e-432f-a91f-0f7030b898b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP424-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE
• Version Model Number: 12003-000-0024
• 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: true
• 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

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109154883 [Primary]
GS1	27290109154880 [Package]; Contains: 17290109154883; Package: Cardboard box [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: 2023-03-22
• Device Publish Date: 2023-03-14

Devices Manufactured by EITAN MEDICAL LTD

• 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
• 27290109152626 - Avoset Pouch Pro: 2024-07-31
• 27290109152152 - AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector: 2024-07-26 MICROBORE (YELLOW STRIPED) INFUSION SET WITH NON-VENTED SPIKE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, V
• 27290109151650 - PCA Lockbox 250 Strap and Pouch: 2024-03-27