VYGON - nutrisafe2 extension tubes with clamp - - VYGON

Duns Number:392994778

Device Description: nutrisafe2 extension tubes with clamp - Ø1.5x2.5mm - L.150cm

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More Product Details

Catalog Number

368.1521

Brand Name

VYGON

Version/Model Number

368.1521

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

0c19a27e-cf76-4986-93de-db0ec3bab48d

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 25, 2019

Additional Identifiers

Package DI Number

53660812105144

Quantity per Package

6

Contains DI Package

33660812105140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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