First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit - First PICC™ S/L Peripherally Inserted Central - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit with Statlock® Stabilizat First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit with Statlock® Stabilization Device 26ga(1.9F) x 50cm

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More Product Details

Catalog Number

384222

Brand Name

First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit

Version/Model Number

384222

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

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Device Record Status

Public Device Record Key

a95b75f4-7029-46db-870d-7edb904f2838

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

February 02, 2017

Additional Identifiers

Package DI Number

20886333223224

Quantity per Package

5

Contains DI Package

00886333223220

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