Vesco Medical ENFit Low Dose Tip Syringe

Basic Information

• Brand Name: Vesco Medical ENFit Low Dose Tip Syringe
• Primary DI: 00850801006387
• Version / Model: VED-601EO
• Catalog Number: VED-601EO
• Company Name: VESCO MEDICAL, LLC
• Labeler DUNS: 079527070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-05
• Public Version: 7
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: a2b5d79b-3c98-4944-8465-8c7f479bdcf0

Device Description

1 mL ENFit Low Dose Tip 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
59040	ENFit oral/enteral syringe, single-use	A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850801006381	GS1	Case	4	In Commercial Distribution
Package	10850801006384	GS1	Inner Pack	200	In Commercial Distribution
Primary	00850801006387	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161979	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 40 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 120 Degrees Fahrenheit