IV Administration Set - IV Administration Set - Health Line International Corporation

Duns Number:806251398

Device Description: IV Administration Set

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

HLSV261822

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

e09b1011-97c8-4de1-b451-1cd0e1368ee8

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

20876604000579

Quantity per Package

4

Contains DI Package

10876604000572

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