Cervos Platelet Separator Single 5 Pack CER-PRP-SINGLE-5

GUDID 10850075308023

CER-PRP-SINGLE-5 F/G, STERILE PN 76158-01M

RANFAC CORP.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 10850075308023
• NIH Device Record Key: 0db96fff-7f23-4843-8061-13a8d925cf54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervos Platelet Separator Single 5 Pack
• Version Model Number: CER-PRP-SINGLE-5
• Catalog Number: CER-PRP-SINGLE-5
• 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: true
• 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

Device Dimensions

• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850075308026 [Primary]
GS1	10850075308023 [Package]; Contains: 00850075308026; Package: Case [12 Units]; In Commercial Distribution

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: 2025-05-22
• Device Publish Date: 2025-05-14

Devices Manufactured by RANFAC CORP.

• 10850075308023 - Cervos Platelet Separator Single 5 Pack: 2025-05-22CER-PRP-SINGLE-5 F/G, STERILE PN 76158-01M
• 10850075308023 - Cervos Platelet Separator Single 5 Pack: 2025-05-22 CER-PRP-SINGLE-5 F/G, STERILE PN 76158-01M
• 10850023741995 - CER-SUB-1590 CE: 2024-10-25 CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M
• 10850023741988 - Cervos Platelet Single B: 2024-09-18 CER-PRP-SINGLE-B F/G, STERILE PN: 76133-01M
• 10857878007313 - MAXX-CELL-3: 2024-09-17 MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M
• 10850023741964 - BANRAN-11: 2024-07-18 BANRAN-11, F/G, STERILE, P/N 76153-01M
• 10850023741896 - CER-PRP-JUVA: 2024-05-23 CER-PRP-JUVA F/G, STERILE PN: 76145-01M
• 00850023741929 - CER-JUVA-BD ASSEMBLY: 2024-05-23 CER-JUVA-BD Assembly PN 69014-01M
• 00850023741936 - CER-PRP-JUVA-KIT: 2024-05-23 CER-PRP-JUVA-KIT F/G, STERILE PN: 76152-01M