Tamper Evident Cap for use with ENFit Syringes

Basic Information

• Brand Name: Tamper Evident Cap for use with ENFit Syringes
• Primary DI: B21257220R1
• Version / Model: 57-220 R
• Catalog Number: 57-220 R
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Labeler DUNS: 053469565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e26e1a48-f5e4-4bd5-ac74-61a19a750193

Device Description

Tamper evident cap for use with ENFit syringes; red; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	876.5980	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	B21257220R2	HIBCC	Box	1000	In Commercial Distribution
Primary	B21257220R1	HIBCC
Unit of Use	B21257220R0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K170672	000