Ivenix, Inc. - LVP Primary Administration Set, Dual-Inlet, - IVENIX, INC.

Duns Number:939332289

Device Description: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, Microbo LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, Microbore (Qty 1)

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More Product Details

Catalog Number

SET-0019-1

Brand Name

Ivenix, Inc.

Version/Model Number

SET-0019-1

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"

Yes

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

e5653124-4ec3-4f42-ab72-54f0480ef178

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

20811505030072

Quantity per Package

25

Contains DI Package

00811505030078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"IVENIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16