VYGON - C-GON Syringe for safety connection Nutrisafe 2 - VYGON

Duns Number:392994778

Device Description: C-GON Syringe for safety connection Nutrisafe 2

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More Product Details

Catalog Number

1015.012

Brand Name

VYGON

Version/Model Number

1015.012

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"

-

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

-

Product Code Details

Product Code

FPD

Product Code Name

TUBE, FEEDING

Device Record Status

Public Device Record Key

96776b29-fd23-4c46-97d4-7b854f779c9e

Public Version Date

October 29, 2021

Public Version Number

8

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

53660812033782

Quantity per Package

32

Contains DI Package

33660812033788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 195