Cervos Platelet Separator Single Pack

GUDID 00850023741660

CER-PRP SINGLE STERILITY PACK PN: 69007-01M

RANFAC CORP.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00850023741660
• NIH Device Record Key: b7ec3557-949c-43a7-99a8-408b211d69f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervos Platelet Separator Single Pack
• Version Model Number: CER-PRP SINGLE
• Company DUNS: 121622872
• Company Name: RANFAC CORP.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter
• Total Volume: 40 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023741660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200543

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: 2022-11-10
• Device Publish Date: 2022-11-02

On-Brand Devices [Cervos Platelet Separator Single Pack]

• 10850023741544: CER-PRP-40-1 Platelet Single Pack PN: 76118-01M
• 00850023741660: CER-PRP SINGLE STERILITY PACK PN: 69007-01M