Contrast Media Set Vented Spike IV Set - Contrast Media Set Vented Spike IV Set with 72" - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Contrast Media Set Vented Spike IV Set with 72" Line

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


More Product Details

Catalog Number

039829999A

Brand Name

Contrast Media Set Vented Spike IV Set

Version/Model Number

039829999A

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"

-

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

6e3c0709-d8db-4cd2-a4d9-3d887ada76d0

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

20886333200768

Quantity per Package

10

Contains DI Package

00886333200764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205