CompoGuard Basic (NA)

Basic Information

• Brand Name: CompoGuard Basic (NA)
• Primary DI: 04086000860741
• Version / Model: 9029641
• Catalog Number: 9029641
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: 8043b9b3-7bca-4f1a-92fc-d67dc5898275

Device Description

Device, Blood Mixing And Weighing

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	864.9195	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36405	Blood donation rocker	A mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes which lie in a cradle-like holder attached to this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04086000860741	GS1

Premarket Submissions

Submission Number	Supplement Number
BK040005	0