AV1010-01 Minibore Extension Set

GUDID 27290109152640

MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use

• Primary Device ID: 27290109152640
• NIH Device Record Key: e7384f87-5491-48f5-bf74-7a99e9051b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AV1010-01 Minibore Extension Set
• Version Model Number: 12222-000-1010
• 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: 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

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109152766 [Primary]
GS1	27290109152640 [Package]; Contains: 17290109152766; Package: [20 Units]; In Commercial Distribution

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: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by EITAN MEDICAL LTD

• 17290109152704 - AV1016-01 Avoset 250mL Medication Reservoir Pouch: 2025-09-08 250mL Medication Reservoir
• 27290109152640 - AV1010-01 Minibore Extension Set: 2025-06-06MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
• 27290109152640 - AV1010-01 Minibore Extension Set: 2025-06-06 MINIBORE INFUSION SET WITH SPIN MALE LUER LOCK, SLIDE CLAMP, SLEEVE, AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
• 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