Tamper Evident Cap

Basic Information

• Brand Name: Tamper Evident Cap
• Primary DI: B2125780K1
• Version / Model: 5780K
• Catalog Number: 5780K
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Labeler DUNS: 053469565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8891832f-d645-43e1-8385-a960cdf5cd70

Device Description

Black Tamper Evident Luer Lock Caps for IV Syringes. Sterile,Individually Blister Packed, box of 100. Provides Evidence of Access and maintains sterility

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: No
• 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
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	B2125780K2	HIBCC	Box	100	In Commercial Distribution
Primary	B2125780K1	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K861276	000