Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867084032
• Version / Model: ABS-10067
• Catalog Number: ABS-10067
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 4
• Public Version Date: 2019-03-22
• Public Version Status: Update
• Public Device Record Key: c3a3ed52-54fa-4cb2-96fa-96cd2031e652

Device Description

ANGEL BLOOD ACCESS KIT (US)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
60336	Blood centrifugation system	An assembly of devices designed for the automated processing of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), in a closed sterile environment using centrifugation to isolate constituent components (e.g., cells, plasma). The assembly typically consists of a mains electricity (AC-powered) processing unit with an integral centrifuge, a disposable kit that includes a centrifugation chamber into which blood is introduced and sedimented into its components during centrifugation, and application-specific protocol software. The system is not donor or patient connected and is typically used for stem cell banking and regenerative medicine.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867084032	GS1
Secondary	M150ABS100671	HIBCC
Package	10888867084039	GS1	Box	8	In Commercial Distribution

Customer Contacts

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