Cervos Platelet Separator Double Pack

Basic Information

• Brand Name: Cervos Platelet Separator Double Pack
• Primary DI: 00850023741301
• Version / Model: CER-PRP-40-2
• Catalog Number: CER-PRP-40-2
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-27
• Public Version: 1
• Public Version Date: 2021-10-05
• Public Version Status: New
• Public Device Record Key: e31dd113-05b7-49cf-8edf-d0014db8eba0

Device Description

CER-PRP-40-2 Platelet Double Pack PN: 76115-01M

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850023741308	GS1	Inner Pack	15	In Commercial Distribution
Primary	00850023741301	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK200543	000

Device Sizes

Type	Value	Unit	Text
Total Volume	40	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat. Protect from freezing. Protect from direct sunlight.