XCELL

Basic Information

• Brand Name: XCELL
• Primary DI: B708ACDA200
• Version / Model: ACD-A-20
• Company Name: APEX BIOLOGIX , LLC
• Labeler DUNS: 079560357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-10
• Public Version: 1
• Public Version Date: 2025-03-18
• Public Version Status: New
• Public Device Record Key: 450cc811-d382-4bf6-a4bb-95788bac1ace

Device Description

ACD-A 20mL Vial Anticoagulant (PN 70-039)

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: No
• 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: Yes
• 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
46812	Blood storage solution, anticoagulation	A blood preservation fluid used during the collection and storage of blood and blood components in a healthcare and/or a blood bank facility (typically in a laboratory associated with the collection of blood or during apheresis procedures that result in the collection of blood), to prevent blood clotting. It is supplied in a container (e.g., a polypropylene bag) and is not for direct intravenous infusion. This is single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B708ACDA200	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temp, avoid freezing and excessive heat