Tamper Evident Cap for Luer Lock IV Syringes

Basic Information

• Brand Name: Tamper Evident Cap for Luer Lock IV Syringes
• Primary DI: B21257302R1
• Version / Model: 57-302 R
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Labeler DUNS: 053469565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 210
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: 2856e54e-708a-4c61-91f2-84c1e05fec05

Device Description

Tamper Evident Cap for Luer Lock IV Syringe

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: 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
63614	Luer-formatted protective cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B21257302R2	HIBCC	Pouch	210	In Commercial Distribution
Primary	B21257302R1	HIBCC
Unit of Use	B21257302R0	HIBCC