Advance Plus Universal IV Administration Set - IV Administration Set, 72" tubing - Exel International

Duns Number:180572216

Device Description: IV Administration Set, 72" tubing

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More Product Details

Catalog Number

1772

Brand Name

Advance Plus Universal IV Administration Set

Version/Model Number

1772

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

448b825b-5cf6-405a-a8be-a8a55667cc91

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

10020221017721

Quantity per Package

60

Contains DI Package

00020221017724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"EXEL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 82