IV Extension Set - IV Extension Set - GERI-GENTLE CORPORATION

Duns Number:361663839

Device Description: IV Extension Set

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More Product Details

Catalog Number

-

Brand Name

IV Extension Set

Version/Model Number

11762

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

-

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

f5a9791b-41c1-425a-aaa3-a71ee11acbd6

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

August 01, 2019

Additional Identifiers

Package DI Number

10369771001263

Quantity per Package

100

Contains DI Package

00369771001266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner

"GERI-GENTLE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23