PCA Lockbox 250mL 15063-000-0001

GUDID 27290109153944

Q-CORE MEDICAL LTD

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• Primary Device ID: 27290109153944
• NIH Device Record Key: 3ee46254-8ec3-4a5c-8e27-4317f120d4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCA Lockbox 250mL
• Version Model Number: 15063-000-0001
• Catalog Number: 15063-000-0001
• 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: 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	07290109153940 [Direct Marking]
GS1	17290109153947 [Primary]
GS1	27290109153944 [Package]; Contains: 17290109153947; Package: [12 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

On-Brand Devices [PCA Lockbox 250mL]

• 07290109150079: 15063-000-0001
• 27290109153944: 15063-000-0001