Sapphire Multi-Pump Mounting System compatible with IPS 15171-000-0004

GUDID 27290109154224

Q-CORE MEDICAL LTD

Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack Medical device integration rack

• Primary Device ID: 27290109154224
• NIH Device Record Key: 9f911ae2-0e28-458a-b890-89975c17e131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire Multi-Pump Mounting System compatible with IPS
• Version Model Number: 15171-000-0004
• Catalog Number: 15171-000-0004
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109154220 [Direct Marking]
GS1	17290109154227 [Primary]
GS1	27290109154224 [Package]; Contains: 17290109154227; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192860

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-15

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