NA

Basic Information

• Brand Name: NA
• Primary DI: 10885403142192
• Version / Model: 4461A
• Catalog Number: 4461A
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-18
• Public Version: 3
• Public Version Date: 2024-02-23
• Public Version Status: Update
• Public Device Record Key: ecc82a39-5d3d-4849-833f-e3e78209c757
• Distribution End Date: 2023-10-02

Device Description

Dry Preoperative Skin Prep Tray With Powder-Free Gloves

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJU	Skin prep tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35246	Surgical patient preparation kit	A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403142190	GS1	Case	20	Not in Commercial Distribution	2023-10-02
Primary	10885403142192	GS1

Customer Contacts

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