Patient Safe®

Basic Information

• Brand Name: Patient Safe®
• Primary DI: 00613703510204
• Version / Model: 51021
• Catalog Number: 51021
• Company Name: RETRACTABLE TECHNOLOGIES, INC.
• Labeler DUNS: 838024255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9166dde5-5f40-445a-bb42-4e18b41bd006

Device Description

Patient Safe® Luer Cap

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: 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: 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16825	Syringe tip cap	A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00613703510228	GS1	Case	160	In Commercial Distribution
Primary	00613703510204	GS1
Unit of Use	00613703510259	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101708	000