Nutriline - NUTRILINE 24 G (2FR) 30 CM CATHETER AND SPLITTING - Vygon Corporation

Duns Number:120818216

Device Description: NUTRILINE 24 G (2FR) 30 CM CATHETER AND SPLITTING NEEDLE

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More Product Details

Catalog Number

1252.30G

Brand Name

Nutriline

Version/Model Number

1252.30G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051690,K051690,K051690

Product Code Details

Product Code

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Device Record Status

Public Device Record Key

ef858907-df54-4b91-9343-29d9f3b67275

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

March 13, 2020

Additional Identifiers

Package DI Number

30849884000857

Quantity per Package

10

Contains DI Package

00849884000856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 833