Celling ART PRP 2-Step 60 Kit 1651-0004

GUDID 00817771028825

ART PRP 2-Step Processing Kit - 60

Celling Biosciences

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00817771028825
• NIH Device Record Key: c9e356b2-34ba-45be-9123-bae9f0b3fbf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celling ART PRP 2-Step 60 Kit
• Version Model Number: 1651-0004
• Catalog Number: 1651-0004
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771028825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK100014

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

Devices Manufactured by Celling Biosciences

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• 00817771027460 - ART BMC System Centrifuge: 2025-04-21 ART BMC System Centrifuge - LXY
• 00817771027484 - ART BMC System Centrifuge: 2025-04-21 ART BMC System Centrifuge - LXY2
• 00817771028788 - Celling ART BMC Plus: 2025-04-21 ART BMC Plus Device
• 00817771028795 - Celling ART BMC: 2025-04-21 ART BMC Processing Device
• 00817771028825 - Celling ART PRP 2-Step 60 Kit: 2025-04-21ART PRP 2-Step Processing Kit - 60
• 00817771028825 - Celling ART PRP 2-Step 60 Kit: 2025-04-21 ART PRP 2-Step Processing Kit - 60
• 00817771028849 - Celling Cardio Application Kit: 2025-04-21 Celling Cardio Application Kit
• 00817771028856 - Celling ART PRP 2-Step 120 Kit: 2025-04-21 ART PRP 2-Step Processing Kit - 120