Integrated Power Supply US 15072-000-0010

GUDID 07290109150208

Q-CORE MEDICAL LTD

Basic power supply Basic power supply Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable

• Primary Device ID: 07290109150208
• NIH Device Record Key: 90969867-7eff-4778-be10-2078202b79d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrated Power Supply US
• Version Model Number: 15072-000-0010
• Catalog Number: 15072-000-0010
• 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: 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
• 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 -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109150208 [Direct Marking]
GS1	17290109150205 [Primary]
GS1	27290109150202 [Package]; Contains: 17290109150205; Package: cardboard box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161667

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-27

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