IV Administration Set - IV Administration Set w/3 Valve Injection Sites - Health Line International Corporation

Duns Number:806251398

Device Description: IV Administration Set w/3 Valve Injection Sites

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More Product Details

Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

HLSV239275MB

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

e632b6c6-7580-413d-9ddd-b5fd07188075

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

20876604001606

Quantity per Package

4

Contains DI Package

10876604001609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HEALTH LINE INTERNATIONAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 64