PCA Lockbox 100 mL 15061-131-0004

GUDID 07290109150024

Q-CORE MEDICAL LTD

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• Primary Device ID: 07290109150024
• NIH Device Record Key: b112187b-24cc-4df0-aa46-8aecf37c0068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCA Lockbox 100 mL
• Version Model Number: 15061-131-0004
• Catalog Number: 15061-131-0004
• 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: 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 -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	07290109150024 [Direct Marking]
GS1	17290109150021 [Primary]
GS1	27290109150028 [Package]; Contains: 17290109150021; Package: cardboard box [12 Units]; 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: 2016-09-01

On-Brand Devices [PCA Lockbox 100 mL]

• 07290109150024: 15061-131-0004
• 27290109153951: 15061-131-0004