Ameritus ENFit

Basic Information

• Brand Name: Ameritus ENFit
• Primary DI: 10817522013237
• Version / Model: ENFCAP-BNS
• Catalog Number: ENFCAP-BNS
• Company Name: KENTEC MEDICAL, INC.
• Labeler DUNS: 066175613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 1
• Public Version Date: 2019-07-01
• Public Version Status: New
• Public Device Record Key: 50ec07ce-6e96-461a-b7da-3644c32421d1

Device Description

Enfit syringe cap

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: 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	30817522013231	GS1	case	10000	In Commercial Distribution
Primary	10817522013237	GS1
Package	20817522013234	GS1	box	500	In Commercial Distribution
Unit of Use	00817522013230	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162188	000