VYGON - Umbilical catheter 4Fr – L.20cm – PUR (double - VYGON

Duns Number:392994778

Device Description: Umbilical catheter 4Fr – L.20cm – PUR (double lumen - 11ml/min / 12ml/min)

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More Product Details

Catalog Number

1274.14

Brand Name

VYGON

Version/Model Number

1274.14

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

FOS

Product Code Name

CATHETER, UMBILICAL ARTERY

Device Record Status

Public Device Record Key

3461d87e-964f-4198-8f1c-b6cb5eb5046c

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Additional Identifiers

Package DI Number

33660812130890

Quantity per Package

10

Contains DI Package

03660812130899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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