NC70000T - IV Insertion Kit - NEOCHILD, LLC

Duns Number:022760922

Device Description: IV Insertion Kit

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More Product Details

Catalog Number

-

Brand Name

NC70000T

Version/Model Number

NC70000T

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

LRO

Product Code Name

General Surgery Tray

Device Record Status

Public Device Record Key

e24723a6-49f4-4272-aa9c-0e41a40802ae

Public Version Date

September 19, 2019

Public Version Number

2

DI Record Publish Date

March 01, 2019

Additional Identifiers

Package DI Number

20816336022128

Quantity per Package

20

Contains DI Package

10816336022121

Package Discontinue Date

September 18, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"NEOCHILD, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 112