Angiography Drape Pack PICC Line - Angiography Drape Pack PICC Line - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Angiography Drape Pack PICC Line

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More Product Details

Catalog Number

401283A

Brand Name

Angiography Drape Pack PICC Line

Version/Model Number

401283A

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

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

9b1e0889-b2c4-4e37-aa79-165fd041a017

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

20886333212969

Quantity per Package

20

Contains DI Package

00886333212965

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