AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP 12000-000-0028

GUDID 27290109150523

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

• Primary Device ID: 27290109150523
• NIH Device Record Key: 9b35d46a-a99c-4a48-b400-e8a5c6632fae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP
• Version Model Number: 12000-000-0028
• Catalog Number: 12000-000-0028
• Company DUNS: 533108028
• Company Name: Q-CORE 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com
• Phone: 1-800-241-4002
• Email: sapphireGCM@icumed.com

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
• 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	17290109150526 [Primary]
GS1	27290109150523 [Package]; Contains: 17290109150526; Package: cardboard box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123049

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by Q-CORE MEDICAL LTD

• 07290109154213 - Sapphire Multi-Pump Mounting Device: 2022-11-14
• 17290109153985 - Infusion Pouch 500mL: 2022-11-14
• 17290109154043 - Homecare Large Backpack: 2022-11-14
• 17290109154050 - Communication Cable -US: 2022-11-14
• 27290109153937 - Multi-Pump Bracket Kit - US (4 units): 2022-11-14
• 27290109154071 - Multi-Pump Mounting System compatible with IPS- A: 2022-05-24
• 17290109153046 - AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE: 2022-05-23
• 27290109153067 - AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA: 2022-05-23