Sapphire M.T. with Bolus and Splitter Kit -US 17000-028-0062

GUDID 07290109150109

Q-CORE MEDICAL LTD

General-purpose infusion pump, line-powered

• Primary Device ID: 07290109150109
• NIH Device Record Key: a65568ea-10dd-4066-abdf-5308cbdf49a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire M.T. with Bolus and Splitter Kit -US
• Version Model Number: 17000-028-0062
• Catalog Number: 17000-028-0062
• Company DUNS: 533108028
• Company Name: Q-CORE MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109150109 [Direct Marking]
GS1	17290109150120 [Primary]
GS1	27290109150127 [Package]; Contains: 17290109150120; Package: cardboard box [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123049

FDA Product Code

• FRN: 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: 2016-09-01

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• 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