Vesco Medical ENFit Low Dose Tip Syringe - 1 mL ENFit Low Dose Tip Syringe - VESCO MEDICAL, LLC

Duns Number:079527070

Device Description: 1 mL ENFit Low Dose Tip Syringe

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More Product Details

Catalog Number

VED-601EO

Brand Name

Vesco Medical ENFit Low Dose Tip Syringe

Version/Model Number

VED-601EO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161979,K161979,K161979

Product Code Details

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

a2b5d79b-3c98-4944-8465-8c7f479bdcf0

Public Version Date

October 29, 2021

Public Version Number

7

DI Record Publish Date

October 05, 2017

Additional Identifiers

Package DI Number

20850801006381

Quantity per Package

4

Contains DI Package

10850801006384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"VESCO MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8