Dr.PRP

GUDID 08809410200060

Rmedica Co.,Ltd

Apheresis system

• Primary Device ID: 08809410200060
• NIH Device Record Key: 1353fe92-e2d9-4553-9313-ccd6e059bd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr.PRP
• Version Model Number: Dr.PRP RMLB-008(1)
• Company DUNS: 694634708
• Company Name: Rmedica Co.,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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com
• Phone: +8228532926
• Email: qm@rmedica.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809410200060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK230818

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: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [Dr.PRP]

• 08809410200060: Dr.PRP RMLB-008(1)
• 08809410200008: Dr.PRP RMLB-008(1)