Selphyl PRFM Tube 0364

GUDID 00851802007120

Blood separation tube for PRFM

Factor Medical, Inc.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00851802007120
• NIH Device Record Key: 46f296c1-c309-4097-b858-0a711767775a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selphyl PRFM Tube
• Version Model Number: 0364
• Catalog Number: 0364
• Company DUNS: 117697569
• Company Name: Factor Medical, Inc.
• 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: 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: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851802007120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170096

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: 2024-08-12
• Device Publish Date: 2024-08-03

Devices Manufactured by Factor Medical, Inc.

• 00851802007113 - Selphyl PRP Tube: 2024-08-12 Blood separation tube for PRP
• 00851802007120 - Selphyl PRFM Tube: 2024-08-12Blood separation tube for PRFM
• 00851802007120 - Selphyl PRFM Tube: 2024-08-12 Blood separation tube for PRFM