EXEL SecureTouch Safety Huber Infusion Set - Safety Huber Infusion Set, non-coring, 19G X 1, - Exel International

Duns Number:180572216

Device Description: Safety Huber Infusion Set, non-coring, 19G X 1, with Y injection site, 7"tube

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More Product Details

Catalog Number

37840

Brand Name

EXEL SecureTouch Safety Huber Infusion Set

Version/Model Number

37840

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

ee06d9be-52f6-4558-8381-a175926143f3

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

30020221378406

Quantity per Package

8

Contains DI Package

10020221378402

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