Oral Tamper Evident Cap

Basic Information

• Brand Name: Oral Tamper Evident Cap
• Primary DI: B21257751
• Version / Model: 57-75
• Catalog Number: 57-75
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Labeler DUNS: 053469565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 8b091983-9f08-4372-9ea3-97e3e42a7242

Device Description

Oral Tamper Evident Cap for NeoMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure

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: 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
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35754	Oral liquid dose dispenser cabinet	An electrically-powered device designed to distribute oral liquid medication/vitamins in a healthcare facility in the amount needed for a single dose for an individual patient. It typically consists of a small cabinet with an electronic pump that contains unit-dose packaged liquid drugs (e.g., glass ampules, sealed plastic containers) and/or containers with multiple doses that dispense an exact amount of liquid at a time.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B21257752	HIBCC	Box	10	In Commercial Distribution
Primary	B21257751	HIBCC
Unit of Use	B21257750	HIBCC