SITE-SCRUB

Basic Information

• Brand Name: SITE-SCRUB
• Primary DI: 10801741086943
• Version / Model: 3882100
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-12-13
• Public Version: 1
• Public Version Date: 2023-12-21
• Public Version Status: New
• Public Device Record Key: e379f175-e856-4b57-b5bd-c0d6329e6fa6

Device Description

Site-ScrubTM IPA Device

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: Yes
• 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
LKB	Pad, alcohol, device disinfectant	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
65043	Intravenous line connector disinfection scrubber	A hand-held device intended to be used to manually disinfect an in-line connector of an intravenous line (e.g., catheter injection port, needleless valve, Luer access valve) with scrubbing to reduce the risk of infection between intravenous administrations. It is in the form of a synthetic polymer cup containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant, and is operated by performing a twisting action over the connector for a few seconds. This device is not designed with a Luer-specific format and is not intended to remain in place after disinfection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00801741086946	GS1
Primary	10801741086943	GS1