PointGuards

Basic Information

• Brand Name: PointGuards
• Primary DI: 00815137021107
• Version / Model: 215
• Company Name: Beekley Corporation
• Labeler DUNS: 001157841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 75
• Record Status: Published
• Publish Date: 2019-07-22
• Public Version: 3
• Public Version Date: 2022-06-02
• Public Version Status: Update
• Public Device Record Key: 372025cb-eb80-40f6-bd79-5b23198cbd3a

Device Description

Temporary Mark Covers, 1.5x5.0cm linear adhesive covers

Device Characteristics

• Single Use: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17812	Needle guard	A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815137021107	GS1
Unit of Use	10815137021104	GS1