Mini Cradle - US 15042-000-0010

GUDID 27290109150004

Q-CORE MEDICAL LTD

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• Primary Device ID: 27290109150004
• NIH Device Record Key: 0a552bb2-5d45-4e13-a5ae-8dbe07c06032
• Commercial Distribution Discontinuation: 2016-10-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mini Cradle - US
• Version Model Number: 15042-000-0010
• Catalog Number: 15042-000-0010
• 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@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.icumed.com
• Phone: 1-800-241-4002
• Email: sapphiregcm@pfe.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109150000 [Direct Marking]
GS1	17290109150007 [Primary]
GS1	27290109150004 [Package]; Contains: 17290109150007; Package: cardboard box [20 Units]; Discontinued: 2016-10-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123049

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: 2016-09-04

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